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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA API® LISTERIA 10STRIPS+10MEDIA

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BIOMERIEUX, SA API LISTERIA 10STRIPS+10MEDIA API® LISTERIA 10STRIPS+10MEDIA Back to Search Results
Model Number 10300
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
An industry customer in (b)(6) notified biomérieux of the misidentification of listeria monocytogenes as listeria welshimeri in association with the api® listeria 10strips+10media (ref. 10300, lot 1007599020). The customer initially cultured the isolate using tsaye and blood agar; an isolate from the tsaye agar was used for identification testing on the api ®listeria strip. The api listeria strip identified the isolate as listeria welshimeri, a non-hemolytic organism. The customer observed beta hemolysis on the blood agar plate; this result contradicted the listeria welshimeri identification provided by the api listeria strip. Biomérieux customer service advised the customer to test the isolate cultured from blood agar and to also test reference sample atcc® 15313 listeria monocytogenes. The customer repeated this test a total of three (3) times, each time the customer sample was identified as listeria welshimeri and the reference sample obtained the correct identification of listeria monocytogenes. The isolate was sent out for identification sequencing and was identified as listeria monocytogenes. As there is no patient associated with this industry sample, there is no adverse event related to any patient's state of health. Biomérieux has initiated an internal investigation.
 
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Brand NameAPI LISTERIA 10STRIPS+10MEDIA
Type of DeviceAPI® LISTERIA 10STRIPS+10MEDIA
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
3145068201
MDR Report Key9885484
MDR Text Key227951758
Report Number9615754-2020-00051
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
C 1 EXEMPT
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 07/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2020
Device Model Number10300
Device Catalogue Number10300
Device Lot Number1007599020
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 Received06/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2019
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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