MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GP TEST KIT

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux that they were informed of a diagnostic error or an impact on patients' health related to the identified anomalies for fsca 3666, in association with the vitek® 2 gp test kit (lot 240303403).The customer stated they reported an identification of staphylcoccus carnosus sp, and the vitek ms gave no identification.The customer stated there was no consequence or impact to the patient's health, as it concerned a multi-resistant strain.The customer informed biomérieux that the vitek lab report was not available and that the identification could not be confirmed on vitek ms.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) had reported to biomérieux that they were informed of a diagnostic error or an impact on patients' health related to the identified anomalies for fsca 3666, in association with the vitek® 2 gp id test kit (lot 240303403).The customer stated they reported an identification of staphylcoccus carnosus sp obtained by the vitek 2 gp id card.Vitek ms gave no identification.The customer did not have the lab report available anymore to submit for further evaluation.An internal biomérieux investigation had been performed regarding discrepancies associated with the impacted gp id lot.The investigation was originally opened to investigate atypical o129r negative reactions with the quality control strain enterococcus casseliflavus atcc® 700327¿ in association with vitek® 2 gp id cards.The investigation determined that an atypical negative o129r reaction was possible for cards manufactured with certain lots of raw material.Testing with these lots could result in a positive dsor reaction that occurs early in the incubation of the card, leading to an earlier hour-of-call and the atypical negative reaction for o129r.An atypical negative o129r reaction may result in an organism misidentification at the species level.Fsca-3595, subsequently superseded by fsca-3666, was issued to inform customers of the gp id lots impacted by the identified qc performance issue.In addition, the field corrective action provided guidance to insure a misidentification causes no adverse impact to a patient.Internal measures have been taken in vitek® 2 reagent manufacturing and quality control to prevent recurrence of this type of issue.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• 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; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7228658
• MDR Text Key: 98644016
• Report Number: 1950204-2018-00052
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

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: 09/25/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420303403
• Other Device ID Number: 03573026131920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1