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U.S. Department of Health and Human Services

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

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BIOMÉRIEUX, SA MEROPENEM MP 32 WW B30 - 513800 Back to Search Results
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.
 
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Brand NameMEROPENEM MP 32 WW B30 - 513800
Type of DeviceMEROPENEM MP 32 WW B30 - 513800
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
jeff scanlan
595 anglum road
hazelwood, MO 
3147318694
MDR Report Key9856990
MDR Text Key206149208
Report Number9615754-2020-00043
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K010363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/17/2022
Device Catalogue Number513800
Device Lot Number1007496370
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 Received06/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
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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