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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX, SA API 20 A 25STRIPS+25MEDIA API® 20 A 25STRIPS+25MEDIA

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BIOMÉRIEUX, SA API 20 A 25STRIPS+25MEDIA API® 20 A 25STRIPS+25MEDIA Back to Search Results
Model Number 20300
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in the (b)(6) notified biomérieux of a misidentification of clostridium bifermentans as clostridium perfringens while testing an external proficiency survey sample with the api® 20 a 25strips+25media (ref 20300, lot 1007917630). According to the proficiency survey report, the sample actually contained clostridium bifermentans at a level of 1950 cfu/g. The profile obtained by the customer was (b)(4) which gave an identification of clostridium perfringens at 99% excellent id. As this was an external proficiency survey sample, there is no patient involved. A biomérieux internal investigation has been initiated.
 
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Brand NameAPI 20 A 25STRIPS+25MEDIA
Type of DeviceAPI® 20 A 25STRIPS+25MEDIA
Manufacturer (Section D)
BIOMÉRIEUX, 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
tenika rhodes
100 rodolphe street
durham, NC 27712
MDR Report Key10680336
MDR Text Key230493167
Report Number9615754-2020-00159
Device Sequence Number1
Product Code JSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
C1 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 01/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/04/2021
Device Model Number20300
Device Catalogue Number20300
Device Lot Number1007917630
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 Received12/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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