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U.S. Department of Health and Human Services

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

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BIOMÉRIEUX, SA MEROPENEM MP 32 US B100 - 513848 Back to Search Results
Catalog Number 513848
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 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 1007583220). The customer stated they inoculated the suspension of the microorganism isolated from the patient's sample into biomérieux mhe agar and applied the meropenem etest strip lot 1007583220; 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 mentioned that a suspension of the same microorganism isolated for the same patient's was tested for antibiotic susceptibility test using vitek® 2 ast-gn79 test kit (ref. 413436) and a mic >16 g/ml was obtained that categorized the strain to be resistant to meropenem. The customer 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.
 
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Brand NameMEROPENEM MP 32 US B100 - 513848
Type of DeviceMEROPENEM MP 32 US B100 - 513848
Manufacturer (Section D)
BIOMÉRIEUX, SA
3 route de port michaud
la balme 39390
FR 39390
Manufacturer (Section G)
BIOMÉRIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key10581120
MDR Text Key209617673
Report Number9615754-2020-00149
Device Sequence Number1
Product Code JWY
UDI-Device Identifier03573026259297
UDI-Public03573026259297
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/29/2022
Device Catalogue Number513848
Device Lot Number1007583220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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