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

Model Number	21347
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of discrepant results associated with vitek® 2 anc test kit.The customer reported that they had a cap survey organism that was identified by vitek® 2 as clostridium clostridiiforme and the expected result was clost septicum.After receiving the cap results, a second swab was tested and the expected result of clost septicum was obtained.No patient is involved in this event.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer from the united states reported to biomérieux a misidentification of a clostridium septicum cap survey sample as clostridium clostridioforme (95%) 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 TEST KIT
• Common Device Name: VITEK® 2 ANC TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 6597321
• Report Number: 1950204-2017-00166
• Device Sequence Number: 91871
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K910666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2018
• Device Model Number: 21347
• Device Lot Number: 2440202103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1