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U.S. Department of Health and Human Services

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

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BIOMÉRIEUX SA API® 20 NE 25STRIPS+25MEDIA Back to Search Results
Catalog Number 20600
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) reported discrepant results of enterococcus faecium instead of the expected e. Gallinarum while using; api 20 ne 25strips+25media. The customer repeated the strips twice and on both occasions; the same result was obtained. There is no evidence/indication of the following: injury or death to a patient; evidence that a patient underwent any unnecessary medical procedure due to the reported event; physician alleging the reported event caused him/her to provide incorrect treatment.
 
Manufacturer Narrative
An internal biomérieux investigation was conducted. Api® 20 strep, rapid id 32 strep, bp card (with vitek® 2 v6. 01 and v7. 01) and vitek® ms on strain lot 2-411 were tested. On api web base (v8. 0), good identification to the genus aerococcus viridans after 4h was obtained and a low discrimination to lactococcus lactis spp lactis, aerococcus viridans or enterococcus faecium (id 1. 7%) after 24h; no identification obtained with api® 20 strep strip. The expected species e. Gallinarum is not included in the api® 20 strep knowledge base. The product is performing as intended within specification.
 
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Brand NameAPI® 20 NE 25STRIPS+25MEDIA
Type of DeviceAPI® 20 NE 25STRIPS+25MEDIA
Manufacturer (Section D)
BIOMÉRIEUX SA
5, rue des aqueducs
craponne, fr 69290
FR 69290
Manufacturer (Section G)
BIOMÉRIEUX SA
5, rue des aqueducs
craponne, fr 69290
FR 69290
Manufacturer Contact
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5513986
MDR Text Key40834903
Report Number3002769706-2016-00057
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
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 03/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number20600
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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