• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA API® NH TEST STRIP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMERIEUX SA API® NH TEST STRIP Back to Search Results
Model Number 10400
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This report was initially submitted following a report of discrepant results associated with api® nh (reference 10400). The customer stated the expected identification as neisseria sicca; however, the result obtained was neisseria gonorrhea 98% (good id). Repeat testing confirmed the misidentification. An internal biomérieux investigation was performed. Due to the expiration (28sep2017) of the incriminated batch (lot 1005423530), testing was not possible; however, the strain, atcc 9913 neisseria sicca, was tested via api nh strips. The results were compliant with a "very good identification" to neisseria spp at 99. 9%. Analysis of the batch record, including bacteriological tests, indicates all criteria for release were compliant. According to the package insert rev 07487p-xl-2016/12 (current version), the knowledge base of the strip is limited to neisseria spp. Complementary tests are necessary to identify the genus to neisseria sicca. Conclusion: due to the expiration of the impacted api nh strips, testing couldn't be performed in the biomérieux qc laboratory. However, a previous study on strain atcc 9913 neisseria sicca at biomérieux showed this strain is correctly identified with the api nh strips.
 
Event Description
A customer in (b)(6) notified biomérieux of discrepant results associated with api nh (reference 10400). The customer reported the expected identification as neisseria sicca and the actual result was neisseria gonorrhoea 98% (good id). Repeat testing confirmed the misidentification. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. A biomérieux internal investigation will be initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAPI® NH TEST STRIP
Type of DeviceAPI® NH TEST STRIP
Manufacturer (Section D)
BIOMERIEUX SA
te, 3 route de port michaud
38390 la balme-les-grottes
FR
Manufacturer (Section G)
BIOMERIEUX SA
te, 3 route de port michaud
38390 la balme-les-grottes
FR
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6917592
MDR Text Key283142626
Report Number3002769706-2017-00289
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCA
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
Type of Report Initial,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2017
Device Model Number10400
Device Lot Number1005423530
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-