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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA API® 20 A STRIPS

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BIOMERIEUX SA API® 20 A STRIPS Back to Search Results
Catalog Number 20300
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
On (b)(6) 2015, a customer contacted biomerieux to report a mis-identification of bifidobacterium species when using api 20 a strips.The customer conducted additional testing with the vitek ms and identified the sample as parabacteroides distasonya.The results from the vitek ms were communicated to the treating physician; there was no delay in results or patient treatment.
 
Manufacturer Narrative
Biomérieux internal investigation was conducted.The strain submitted by the customer was tested via the following methods: api® 20 a strips (two strips each from customer lot and a random lot).Vitek® 2 anc id test kit.Vitek® ms.All test methods returned the expected result of parabacteroides distasonis.The discrepant result obtained by the customer could not be reproduced.The api 20 a strip is performing in accordance with specifications.
 
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Brand Name
API® 20 A STRIPS
Type of Device
API® 20 A STRIPS
Manufacturer (Section D)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR  69280
Manufacturer (Section G)
BIOMERIEUX SA
chemin de l orme
marcy l etoile, rhone 69280
FR   69280
Manufacturer Contact
ryan lemelle
595 anglum road
hazelwood, MO 63042
3147318582
MDR Report Key5180884
MDR Text Key30041316
Report Number3002769706-2015-00130
Device Sequence Number1
Product Code JSP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
CL I, EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2016
Device Catalogue Number20300
Device Lot Number1003848900
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/08/2015
Initial Date FDA Received10/27/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/06/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/12/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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