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

Catalog Number	21342
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 the united states notified biomérieux of discrepant results associated with vitek®2 gp test kit (reference 21342).The customer reported having a patient with blood culture isolate that identified twice as pediococcus.The isolate was sent out to a reference laboratory and the identification for the isolate is streptococcus sanguinis.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to a customer reporting a misidentification of streptococcus sanguis (identification from reference lab) as pediococcus pentosaceus with the vitek® 2 gp id card.Note: s.Sanguis is the former name for s.Sanguinis which is the nomenclature recognized in the vitek 2 gp knowledge base.The customer submitted their strain for evaluation.The submitted strain was subcultured to tsab and incubated at 37°c in co2 atmosphere.The vitek 2 gp id card testing included individual organism suspensions with cards from the customer lot (2420617403) and a random lot (2420561103) in duplicate.Additional testing included vitek ms and api 20 strep kit.911634 : two gp cards tested resulted in excellent identifications of streptococcus anginosus and the remaining two gp cards resulted in low discrimination identifications streptococcus anginosus / streptococcus gordonii.Vitek ms resulted in an identification of s.Anginosus with a 99.9% confidence value and api 20 strep kit resulted in a 91.1 % identification of s.Anginosus.The final identification of this strain is s.Anginosus.A review of the customer's p.Pentosaceus reactions demonstrated eight atypical negative reactions ( amy, appa, phos, tyra, polyb, lac, novo, adh2s) for an identification of s.Anginosus according to the gp knowledge base.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.The vitek 2 gp id cards performed as expected.

• Brand Name: VITEK®2 GP TEST KIT
• Common Device Name: VITEK®2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7679674
• Report Number: 1950204-2018-00252
• Device Sequence Number: 1577847
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: Health Professional
• Device Expiration Date: 08/05/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420617403
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1