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U.S. Department of Health and Human Services

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

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BIOMERIEUX, SA API 20 STREP STRIPS API® 20 STREP STRIPS Back to Search Results
Model 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) notified biomerieux of incorrect well reactions for hippuric acid (hip), beta-galactosidase (bgal), and peptidoglycan-associated lipoprotein (pal) for an external qc streptococcus dysgalactiae strain using api 20 strep 25strips+25media strips (reference (b)(4)). The results the customer obtained were consistent with aerococcus urinae not streptococcus dysgalactiae. Biomerieux customer service requested additional information about this event including lot number and sample preparation technique. Additionally, customer service recommended to perform qc tested using isolates that are listed in the api 20 strep 25strips+25media package insert. At the time of this assessment no additional information has been provided as there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. Biomerieux will initiate an internal investigation.
 
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Brand NameAPI 20 STREP STRIPS
Type of DeviceAPI® 20 STREP STRIPS
Manufacturer (Section D)
BIOMERIEUX, 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
matthew locus
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9296602
MDR Text Key219765298
Report Number9615754-2019-00118
Device Sequence Number1
Product Code JTO
UDI-Device Identifier03573026048440
UDI-Public03573026048440
Combination Product (y/n)N
Reporter Country CodeJA
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 07/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20600
Device Catalogue Number20600
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 Received06/09/2020
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 Initial

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