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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX, INC. BACT/ALERT FA PLUS (PLASTIC)

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BIOMÉRIEUX, INC. BACT/ALERT FA PLUS (PLASTIC) Back to Search Results
Catalog Number 410851
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Intended use: bact/alert fa plus culture bottles are used with bact/alert microbial detection systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic (bacteria and yeast) from blood and other normally sterile body fluids. Issue description: a customer in the united states notified biomérieux of experiencing an increase in the number of contaminations observed after inoculation in association with bact/alert fa plus (plastic) (ref. (b)(4), batch number 0004100660, expiration date 14-dec-2022) regarding patient samples with the bact/alert virtuo system. The customer reported that seven (7) positive fa plus bottles were determined to contain staphylococcus hominis and staphylococcus epidermidis. The contaminants being reported by the customer are skin contaminants. The specific source for the contaminants has not yet been determined. There is no indication or report from the customer that these false positive results led to any adverse event related to any patient's state of health. Updated scope on the (b)(6) 2022: the number of bottles was initially mentioned as 6-7 bottles and was finally updated to 6 bottles. An investigation will be initiated.
 
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Brand NameBACT/ALERT FA PLUS (PLASTIC)
Type of DeviceBACT/ALERT FA PLUS (PLASTIC)
Manufacturer (Section D)
BIOMÉRIEUX, INC.
100 rodolphe street
durham NC 27712
Manufacturer (Section G)
BIOMÉRIEUX, INC.
100 rodolphe street
durham NC 27712
Manufacturer Contact
céline strauel
5, rue des aqueducs
craponne 69290
FR   69290
MDR Report Key15233831
MDR Text Key302866992
Report Number3002769706-2022-00036
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026357900
UDI-Public03573026357900
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121461
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number410851
Device Lot Number0004100660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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