MAUDE Adverse Event Report: BIOMÉRIEUX, SA MEROPENEM MP 32 WW B30 - 513800

Catalog Number 513800

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

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

On 18-feb-2020, a customer in (b)(6) notified biomérieux of an mic underestimation (false intermediate) for meropenem when testing a klebsiella pneumoniae patient isolate with etest® meropenem (ref.513800, lot 1007496370).Vitek® 2 ast testing gave meropenem resistant results (mic >8) on two (2) different ast card types, while the impacted lot of etest® meropenem obtained a mic value = 3 mg/l, intermediate.The customer performed pcr testing of the strain and obtained a ndm (carbapenemase) positive result.Colistin was resistant.The isolate has been sent to a reference laboratory for carbapenemase testing; no results have been provided by the customer.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in germany regarding an mic underestimation (false intermediate instead of resistant) for meropenem when testing a klebsiella pneumoniae patient isolate with etest® meropenem (ref.(b)(4), lot 1007496370).Biomérieux investigation was conducted.Manufacturing batch records for etest® meropenem ref 513800 lot 1007496370 were evaluated.All specifications were met.Batch testing: testing of the customer lot and a reference lot was performed with six (6) atcc® strains.Three strips of each lot were tested.All atcc® strains obtained conforming results for both lots tested.Reproducibility testing and reference method on customer strains: id testing: identification confirmed to klebsiella pneumonia ssp pneumonia.Reference method via agar dilution (ad) to determine the expected meropenem mic: ertapenem mic = 4 mg/l intermediate.The customer¿s submitted strain was tested on the impacted customer lot (1007496370) and an internal reference lot (1007900020).Customer lot ertapenem mic=16 mg/l (resistant); reference lot ertapenem mic= 32 mg/l (resistant).Conclusion: the qc results obtained during this investigation are in accordance with specification for the impacted lot 1007496370.The etest mp32 results obtained by the customer were not reproduced internally.An heterogeneous production of carbapenemase was detected for the strain.Etest method allows the detection of such hetero-resistance and is then correlated with the ndm and vim carbapenemase phenotypes obtained by the customer with pcr.As a conclusion, the investigation did not identify any product performance issue.See h10.

• Brand Name: MEROPENEM MP 32 WW B30 - 513800
• Type of Device: MEROPENEM MP 32 WW B30 - 513800
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 39390 ; FR 39390
• MDR Report Key: 9856990
• MDR Text Key: 206149208
• Report Number: 9615754-2020-00043
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Catalogue Number: 513800
• Device Lot Number: 1007496370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1