MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK®2 GN ID CARD

Catalog Number	21341
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of discrepant results associated with vitek®2 gn id card (reference (b)(4)).The customer reported salmonella enterica subsp.Enterica servor diarizonae was identified with gn cards.The customer considered this was not salmonella according to antiserum and other testing was performed which resulted in citrobacter freundii.The other tests were performed with tsi media and sim media, but not with api®, vitek ms or 16s.The correct result of c.Freundii was reported to the physician.There was no delay in reporting results.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) had reported a misidentification of citrobacter freundii or escherichia coli as salmonella enterica ssp diarizonae when tested in the vitek® 2 gn card (lot #2410495203) using vitek 2 software version 7.01.The strain was identified as c.Freundii by other tests performed from tsi and sim media and as e.Coli by repeat testing and a third party laboratory.An internal biomérieux investigation was initiated; however, the customer's strain and raw data were not available for investigation.No set up information was provided.The customer did not provide the methodology that determined the strain was a c.Freundii.No vitek 2 gn results were provided for the repeat testing that identified the strain as e.Coli.It is not clear which identification is the reference identification.Three (3) lab reports were submitted with all showing an excellent identification of s.Enterica ssp diarizone.There were four (4) atypical reactions on one (1) lab report (+: odc, ldc, bgur and -:5kg) and three (3) atypical reactions (+: ldc, bgur and -:5kg) on two (2) lab reports for an identification of c.Freundii according to the gn knowledge base.If the strain was e.Coli, there was one (1) atypical positive reaction (h2s) for an identification of e.Coli according to the gn knowledge base.Atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non-recommended media or other user set up errors, or an atypical strain.However, without the strain or raw data it was not possible to further evaluate the cause of the misidentification.Note: any identification of salmonella should be confirmed with another method such as serology.The vitek 2 gn lab report prints the message "confirm by serological tests" for any identification of salmonella sp.The vitek 2 gn card (lot # 2410495203) met final qc release criteria and passed qc performance testing.

• Brand Name: VITEK®2 GN ID CARD
• Common Device Name: VITEK®2 GN ID CARD
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7885702
• Report Number: 1950204-2018-00372
• Device Sequence Number: 11444594
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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
• Operator of Device: No Information
• Device Expiration Date: 04/05/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410495203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1