MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Biomérieux investigation has been conducted.Investigational testing of the isolate included.Vitek® 2 gp id (customer lot and random lot, two cards each): all four gp id cards tested resulted in excellent and very good identifications of enterococcus gallinarum.Api® 20 strep: observed no yellow pigmentation and tested hip-positive on the api® test kit, consistent with enterococcus gallinarum.The investigation concluded the vitek® 2 gp id test kit is performing as intended.Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of cap survey strain enterococcus gallinarum as enterococcus casseliflavus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Repeat test obtained a slash-line call of enterococcus gallinarum / enterococcus casseliflavus.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey strain.Biomérieux investigation will be initiated.

Manufacturer Narrative

Customer in the us reported to biomérieux discrepant results and qcv failure in association with the vidas® analyzer (reference (b)(4)).An investigation was performed.Note: observing a qcv failure is not abnormal as the qcv is a functional control meant to detect residual risks, that are rare and sudden.These risks are already present and accepted into the vidas system risk analysis.As requested by biomérieux, the customer performed a retrospective analysis for tests which were performed on the instrument.This retrospective analysis included re-running all tests which were run from (b)(6) 2017 (date of the last conform qcv) to (b)(6) 2017 (date of the qcv failure).According to the customer, the retrospective analysis showed that six (6) patient samples were affected : · 2 mpg results were reported as negative instead of positive; · 4 vzg results were reported as negative instead of positive.As stated by the customer, all other tests had the same result.For the six (6) false results, the customer stated that reports were corrected and that the doctors were notified.The customer confirmed that there was no consequence for the patients, no patient was harmed or treated incorrectly, and no patient was a pregnant woman, child, or immune-compromised.The investigation by the field service engineer (fse) at the customer site, identified the root cause of the qcv failure as a clog.This clog was confirmed by a result value not conforming when using the pump tester.The fse replaced the pump seals and cleaned with the pump cleaner.Then the result value of the pump tester was conforming, as the instrument was repaired.The fse performed a leak test and a qcv test and qualified the instrument.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6384333
• MDR Text Key: 69272480
• Report Number: 1950204-2017-00083
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242394310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: 06/27/2017
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1