MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-GN81 TEST KIT

Catalog Number	413438
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) reported false resistant carbapenems in association with the vitek® 2 ast-gn81 test kit (lot 6710736203).The customer reported that false resistant ertapenem and meropenem results were obtained for two (2) escherichia coli patient strains, with lot 6710736203.Retesting with new lot 6710840403 gave susceptible results.Etest® for ertapenem and meropenem gave susceptible results.Patient 1: lot 6710736203 - ertapenem mic >=8 r; meropenem mic >=16 r, lot 6710840403 - ertapenem mic <=0.5 s; meropenem mic <=0.25 s.Patient 2: lot 6710736203 - ertapenem mic >=8 r; meropenem mic >=16 r, lot 6710840403 - ertapenem mic <=0.5 s; meropenem mic <=0.25 s.No patient information was provided by the customer.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for false resistant carbapenems (meropenem, ertapenem) in association with the vitek® 2 ast-gn81 test kit (lot 6710736203).The customer's test reports were evaluated.Two strains gave resistant results with the initial lot number (6710736203) with consistent, or consistent with correction, confidence.Susceptible results for the two strains were obtained with the new lot number (6710840403).One strain had inconsistent results with the old lot number (6710736203).The customer did not submit the strains for evaluation.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to the reference method.The vitek 2 ast-gn81 lot# 6710736203 and 6710840403 met final qc release criteria.These lots passed qc performance testing.

• Brand Name: VITEK® 2 AST-GN81 TEST KIT
• Common Device Name: VITEK® 2 AST-GN81 TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8126949
• Report Number: 1950204-2018-00599
• Device Sequence Number: 1721524
• Product Code: LON
• UDI-Device Identifier: 03573026399030
• UDI-Public: 03573026399030
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K152075
• 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): 01/29/2019

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: 12/02/2019
• Device Catalogue Number: 413438
• Device Lot Number: 413438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1