MAUDE Adverse Event Report: BIOMERIEUX, SA ETEST® MEROPENEM MP 32 WW B30

Catalog Number 513800

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a false susceptible meropenem result for a klebsiella pneumoniae external quality control sample ((b)(4), specimen (b)(6)) in association with etest® meropenem mp 32 ww b30.The customer repeated the etest three times and reported a susceptible (mic=1.5) result, when the expected was resistant.(mc=16).The isolate was also tested on the vitek® ast-n350 card in which meropenem was resistant (mic>=16).There was no patient involvement as the event pertained to a quality survey sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a false susceptible meropenem result for a klebsiella pneumoniae external quality control sample (uk neqas distribution 4297, specimen 4431) in association with etest® meropenem mp 32 ww b30.Biomérieux investigated the retained samples of lot 1004872950.The conformity of lot 1004872950, and an internal reference lot 1006887150 was confirmed with the atcc quality control strains tested for the release of this reference: atcc (b)(6) escherichia coli, atcc (b)(6) enterococcus faecalis, atcc (b)(6) streptococcus pneumoniae, atcc (b)(6) pseudomonas aeruginosa, atcc (b)(6) haemophilus influenzae, atcc (b)(6) bacteroides fragilis.A complain trend analysis confirmed there was no other complaint registered on the lot.The identification of the neqas strain to klebsiella pneumoniae was confirmed with vitek ms methodology.The neqas strain was tested with the etest mp 32 lot 1004872950 mentioned by the customer, and an internal reference lot 1006887150.The results obtained with two lots were >32 g/ml, categorized as resistant based on eucast breakpoints.Conclusion: the susceptible result obtained with etest mp 32, lot 1004872950, by the customer was not reproduced in-house.The results obtained with etest meropenem mp 32, lot 1004872950, and the atcc quality control strains tested during the investigation conformed with specifications.Etest results on the neqas strain was correlated to expected result for meropenem: resistant.

• Brand Name: ETEST® MEROPENEM MP 32 WW B30
• Type of Device: ETEST® MEROPENEM MP 32 WW B30
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 8087135
• MDR Text Key: 129331356
• Report Number: 3002769706-2018-00243
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K010363
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2019
• Device Catalogue Number: 513800
• Device Lot Number: 1004872950
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1