MAUDE Adverse Event Report: BIOMÉRIEUX, SA MEROPENEM MP 32 US B100 - 513848

Catalog Number	513848
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 from the united states notified biomérieux of discrepant meropenem susceptible results when testing klebsiella pneumonia strains isolated from a patient's sample using etest® method (ref.513848, lot 1007735480).The customer stated they had inoculated the suspension of the microorganism isolated from the patient's sample into biomérieux mhe agar and applied the meropenem strip lot 1007735480; after incubation the customer obtained a meropenem mic value of 0.25 g/ml, categorizing the strain to be susceptible to this antimicrobial agent.The customer indicated that they had also performed carbanp test for carbapenemase detection and a positive result was obtained; this is not consistent with the susceptible result to meropenem.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.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the united states regarding discrepant meropenem susceptible results when testing klebsiella pneumoniae strains isolated from a patient's sample using etest® method (ref.(b)(4), lot 1007735480).The investigation included testing multiple quality control (qc) strains using the retain samples of this impacted lot 1007735480 as well as two other lots, 1007583220 and 1008195550.The qc results obtained for the strains tested were in accordance with the expected specifications and equivalent between the three lots of etest mp 32.No product performance issues were observed during the quality control investigation.The customer¿s strain was returned to biomerieux for testing.Analysis of the strain confirmed the strain was klebsiella pneumoniae ssp pneumoniae.Whole genome sequencing (wgs) was performed, and it confirmed the presence of a carbapenemase-producing strain (presence of the gene kpc-3).The customer¿s susceptible results obtained with etest® mp 32 lot number 1007735480 was reproduced internally on the strain provided.Tthe strain was tested with the agar dilution (ad) methodology as it was the reference method used for the etest® meropenem (mp 32) development and with three lots of etest® mp 32 strips (lot numbers 1007583220,1007735480, and 1008062280).The etest® mp 32 mics (0.5 g/ml, 0.5 g/ml, and 0.25 g/ml, respectively) were within essential agreement compared to the reference mic (agar dilution 0.25 g/ml, susceptible) without any category error.The device performed as expected.This phenomenon with some strains characterized as ¿carbapenemase-producing bacteria ¿ and having a low susceptibility to carbapenems, is known.

• Brand Name: MEROPENEM MP 32 US B100 - 513848
• Common Device Name: MEROPENEM MP 32 US B100 - 513848
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme ; FR
• MDR Report Key: 10581078
• Report Number: 9615754-2020-00148
• Device Sequence Number: 3449768
• Product Code: JWY
• UDI-Device Identifier: 03573026259297
• UDI-Public: 03573026259297
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010363
• 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): 11/23/2020

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: 11/12/2022
• Device Catalogue Number: 513848
• Device Lot Number: 1007735480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1