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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, SA API® 20 STREP

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BIOMERIEUX, SA API® 20 STREP Back to Search Results
Catalog Number 20600
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
A customer in (b)(6) reported a misidentification of an enterococcus gallinarum survey sample (cqe ecbu 2018-3a prospective biology 11. 1646 ) as enterococcus faecium in association with the api® strep test strip. The customer repeated the test several times with several lots and from different culture media, and obtained the same result. The quality control was conforming. There was no patient involvement as the event pertained to a survey sample. A biomérieux internal investigation will be initiated.
 
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Brand NameAPI® 20 STREP
Type of DeviceAPI® 20 STREP
Manufacturer (Section D)
BIOMERIEUX, SA
3 route de port michaud
la balme, les grottes isere 38390
FR 38390
Manufacturer (Section G)
BIOMERIEUX, SA
3 route de port michaud
la balme, les grottes isere 38390
FR 38390
Manufacturer Contact
debra broyles
595 anglum road
hazelwood, MO 63042
MDR Report Key8087036
MDR Text Key129301511
Report Number3002769706-2018-00242
Device Sequence Number1
Product Code JTO
UDI-Device Identifier03573026048440
UDI-Public03573026048440
Combination Product (y/n)N
Reporter Country CodeFR
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 02/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2019
Device Catalogue Number20600
Device Lot Number1006278700
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 Received01/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2018
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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