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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA ETEST ERTAPENEM ETP 32 WW B30 ERTAPENEM ETP 32 WW B30 - 531600

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BIOMERIEUX SA ETEST ERTAPENEM ETP 32 WW B30 ERTAPENEM ETP 32 WW B30 - 531600 Back to Search Results
Catalog Number 531600
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 in (b)(6) notified biomérieux of false resistant ertapenem results for a patient morganella morganii isolate in association with the etest® ertapenem etp 32 ww (ref 531600, lot 1007351040). Repeat testing with the etest® ertapenem etp 32 ww was not performed. The isolate was also tested with the vitek® 2 ast-n233+xn05 and the vitek® 2 ast-n372. The initial test with the vitek® 2 ast-n372 obtained a resistant result while repeat testing with both the vitek® 2 ast-n372 and vitek® 2 ast-n233+xn05 obtained susceptible results. Initial result with the vitek® 2 n372 cards: ertapenem mic > 4 mg/l (resistant). Initial vitek® 2 n233+xn05: ertapenem mic <
=
0. 5 mg/l (susceptible). Repeat vitek®2 n372: ertapenem mic <
=
0. 12 mg/l (susceptible). Repeat vitek®2 n233+xn05: ertapenem mic <
=
0. 5 mg/l (susceptible). Etest® ertapenem: ertapenem mic
=
1. 5 mg/l (resistant). There is no indication or report from the laboratory that the false resistant result led to any adverse event related to a patient's state of health. A biomérieux internal investigation will be initiated. Note: ref 531600 is not sold/marketed in the united states; however, an equivalent product (ref 531640) is sold/marketed in the united states.
 
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Brand NameETEST ERTAPENEM ETP 32 WW B30
Type of DeviceERTAPENEM ETP 32 WW B30 - 531600
Manufacturer (Section D)
BIOMERIEUX SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme 38390
FR 38390
Manufacturer Contact
matthew locus
595 anglum road
hazelwood, MO 63042
MDR Report Key9729570
MDR Text Key206147870
Report Number9615754-2020-00029
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K020748
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 06/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2022
Device Catalogue Number531600
Device Lot Number1007351040
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 Received05/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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