Device - Adverse Events API Endpoint: mdr_text patient_sequence_number indexing from 0 instead of 1

[NINEam-t]

Hello,

I've observed numerous records where the "patient_sequence_number" within the "mdr_text" array is counting starting from 0 rather than 1. This "patient_sequence_number" enumeration should align with the "patient_sequence_number"(s) within the "patient" array. MAUDE enumerates patient sequence beginning with 1 (as shown in the MAUDE screenshot, example 1b, below).

1a) openFDA

1b) MAUDE

I can provide additional examples/screen shots if needed. Below are a few more "mdr_report_key"s:

mdr_report_key

11197921
11226972
11363208
11770544
12016535
12149454
12573120
12606192

Thank you in advance for any help you can provide!

[dkrylovsb]

openFDA generates its Device AE endpoint from the FDA MAUDE's downloadable files, and the problem appears to originate from the source files themselves:

(_python-env) bash-3.2$ grep "12016535" foitext*
foitext2021.txt:12016535|280760018|N|0||THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE EVENT DESCRIPTION PROVIDED BY THE DISTRIBUTOR STATES THAT THE HAPTIC BROKE AND THE CAPSULE RUPTURED DURING IMPLANTATION RESULTING IN THE LENS FALLING INTO THE VITREOUS. THE SURGICAL PROCEDURE WAS EXTENDED AND A RETINAL SPECIALIST PERFORMED A VITRECTOMY. THE FACT THAT THE LENS WAS DELIVERED WITH A BROKEN HAPTIC MAY SUGGEST THAT THE LENS BECAME TRAPPED DURING INJECTION AND THAT CONTINUED DEPRESSION OF THE PLUNGER HAS CAUSED FASTER EXPULSION OF THE IOL FROM THE INJECTOR RESULTING IN PC RUPTURE. THE PRODUCT IS NOT AVAILABLE FOR RETURN IN THIS CASE. IT WAS DISCARDED FOLLOWING USE/EXPLANT. (B)(4). RAYNER IS CONTINUING TO FOLLOW-UP WITH ITS SALES AGENT TO OBTAIN ADDITIONAL INFORMATION (INCLUDING PATIENT MEDICAL HISTORY, AS THERE ARE CERTAIN CONDITIONS THAT MAY MAKE A PATIENT MORE PRE-DISPOSED TO PC RUPTURE) TO FACILITATE FURTHER INVESTIGATION OF THIS EVENT. THIS IS AN ISOLATED REPORT. A REVIEW OF EXISTING VIGILANCE DATA CONFIRMS THAT NO OTHER INCIDENTS, OF ANY TYPE, HAVE BEEN RECEIVED AGAINST THE RAYONE EMV RAO200E BATCH 031164682. OUR REVIEW OF PRODUCTION RECORDS FOR THE RAYONE EMV RAO200E BATCH 031164682 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL DEVICES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS.
foitext2021.txt:12016535|280760019|D|0||ON (B)(6) 2021, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS US AFFILIATE COMPANY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE HAPTIC BROKE DURING IMPLANTATION AND THAT THE CAPSULAR BAG RUPTURED RESULTING IN THE LENS FALLING THROUGH THE VITREOUS.

We will work with the FDA CDRH to see if this can be corrected on their end; unfortunately until that happens the Device AE endpoint will continue to exhibit this issue.

Sorry about the inconvenience.

[NINEam-t]

Thanks, Denis, I meant to check that. It's good to have you back!