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

Catalog Number 21347

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states contacted biomérieux to report a misidentification of cap survey strain clostridium septicum as clostridium clostridiforme in association with the vitek® 2 anaerobic and corynebacteria (anc) identification (id) test kit.Upon the advice of biomérieux support personnel, the customer repeated testing using a second swab; the expected cap id of clostridium septicum was obtained.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 conducted.

Manufacturer Narrative

A customer from the united states reported to biomérieux a misidentification of a clostridium septicum cap survey sample as clostridium clostridioforme in association with the vitek® 2 anc test kit.An investigation was performed.The biomérieux internal lyophilized cap sample d-04 was reconstituted and subbed onto anaerobic cdc agar, which was incubated under anaerobic conditions for 24 hours, and tested on three different vitek® 2 anc lots.Vitek® ms testing was also performed.All three card lots tested obtained an excellent id (99%) of c.Septicum.The vitek® ms also identified the organism as c.Septicum, with a 99.9% confidence value.When customer lab reports with the incorrect ids of c.Clostridioforme were examined, it was noted that a "gram negative" result was entered for offline testing instead of "gram positive".This resulted in c.Clostridioforme being identified instead of c.Septicum.In some of these cases, there was also one atypical negative result (bdfuc) when compared to expected reaction results for c.Septicum.In conclusion the vitek® 2 anc test kit.Performed as expected and no further action is necessary.

• Brand Name: VITEK® 2 ANC ID TEST KIT
• Type of Device: VITEK® 2 ANC ID 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6605333
• MDR Text Key: 76526096
• Report Number: 1950204-2017-00175
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910666
• 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: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440082403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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