MAUDE Adverse Event Report: BIOMERIEUX SA ETEST ERTAPENEM ETP 32 WW B30; ERTAPENEM ETP 32 WW B30 - 531600

Catalog Number 531600

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of false resistant ertapenem results for a patient morganella morganii isolate in association with the etest® ertapenem etp 32 ww (ref 531600, lot 1007351040).Repeat testing with the etest® ertapenem etp 32 ww was not performed.The isolate was also tested with the vitek® 2 ast-n233+xn05 and the vitek® 2 ast-n372.The initial test with the vitek® 2 ast-n372 obtained a resistant result while repeat testing with both the vitek® 2 ast-n372 and vitek® 2 ast-n233+xn05 obtained susceptible results.Initial result with the vitek® 2 n372 cards: ertapenem mic > 4 mg/l (resistant).Initial vitek® 2 n233+xn05: ertapenem mic <= 0.5 mg/l (susceptible).Repeat vitek®2 n372: ertapenem mic <= 0.12 mg/l (susceptible).Repeat vitek®2 n233+xn05: ertapenem mic <= 0.5 mg/l (susceptible).Etest® ertapenem: ertapenem mic = 1.5 mg/l (resistant).There is no indication or report from the laboratory that the false resistant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.Note: ref 531600 is not sold/marketed in the united states; however, an equivalent product (ref 531640) is sold/marketed in the united states.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of false resistant ertapenem results for a patient morganella morganii isolate in association with the etest® ertapenem etp 32 ww (ref 531600, lot 1007351040).Internal retention samples of the customer's lot (1007351040) as well as a reference lot (1006530990) were used for investigational testing purposes.Quality control (qc) testing: qc (atcc®) strains were tested on both the customer lot and the reference lot of etest® ertapenem etp 32 ww.All qc strains obtained the expected qc results for both lots tested.Customer's strain: the customer submitted the strain for investigational testing.The identification was confirmed to be morganella morganii ssp morganii with the vitek® 2 gn id test kit.The customer's strain was tested with: agar dilution method (ad) since this is the reference method used for the development of the etest® etp32.Etest etp32 strips - customer's lot (1007351040) and reference lot (1006530990) casfm eucast 2020 clinical breakpoints were used to categorize the mic values [s < = 0.5 ; r > 0.5].The following results were obtained: ad ertapenem mic = 0.032 mg/l (susceptible).Etest etp32 mic = 0.016 mg/l (susceptible) on both lots tested.Etest etp32 mics are within essential agreement compared to the reference mics (ad) without any category error.Conclusion: the customer's resistant results were not reproduced internally.The etest etp32 mics are within essential agreement compared to the reference method ad mic (one doubling dilution between both).A trend analysis of the complaints does not indicate a trend for etest etp32 reference 531600.As a conclusion, the performance of etest etp32 is within specifications and as the investigation did not identify any product performance issue.

• Brand Name: ETEST ERTAPENEM ETP 32 WW B30
• Type of Device: ERTAPENEM ETP 32 WW B30 - 531600
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 9729570
• MDR Text Key: 206147870
• Report Number: 9615754-2020-00029
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K020748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 531600
• Device Lot Number: 1007351040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1