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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX SA PREVI COLOR GRAM INSTRUMENT V2 - 414292; PREVI COLOR GRAM INSTRUMENT V2- 414292

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BIOMÉRIEUX SA PREVI COLOR GRAM INSTRUMENT V2 - 414292; PREVI COLOR GRAM INSTRUMENT V2- 414292 Back to Search Results
Model Number 414292
Device Problem Unexpected Color (4055)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Intended use: the previ® color gram has been designed to perform automated gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics.Issue description: a customer in france notified biomérieux of staining issues associated with previ color gram instrument v2 - ref.414292, lot 414292202374.The customer indicated that these issues have been ongoing for the last year.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.
 
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Brand Name
PREVI COLOR GRAM INSTRUMENT V2 - 414292
Type of Device
PREVI COLOR GRAM INSTRUMENT V2- 414292
Manufacturer (Section D)
BIOMÉRIEUX SA
376 chemin de l'orme
marcy l'etoile 69280
FR  69280
Manufacturer (Section G)
BIOMÉRIEUX SA
376 chemin de l'orme
marcy l'etoile 69280
FR   69280
Manufacturer Contact
benjamen jost
595 anglum road
hazelwood, MO 63042
MDR Report Key16618113
MDR Text Key312376153
Report Number8020790-2023-00021
Device Sequence Number1
Product Code KPA
UDI-Device Identifier03573026415310
UDI-Public03573026415310
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
C1 EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number414292
Device Catalogue Number414292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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