BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 14468795 · Received May 23, 2022

    Report

    Report Number
    3003045237-2022-00002
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 25, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K180269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS TO BE RETURNED FOR FURTHER INVESTIGATION. THE INSTRUMENT STILL HAS NOT BEEN RECEIVED IN OSLO. THEREFORE, RETURN TESTING HAS NOT BEEN PERFORMED. THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT IS NOT RELATED TO PRODUCT RESULTS, INADEQUATE INSTRUCTIONS FOR USE OR INACCURATE LABELS.

    Description of Event or Problem · 0

    CUSTOMER REPORT OF SPARKING FOR AFINION AS100 ANALYZER WHILE DOING A PATIENT TEST. SPARKING WAS SEEN BETWEEN THE POWER CORD AND THE ANALYSER, THE CUSTOMER WAS UNABLE TO SPECIFY IF SPARK WAS FROM POWER CORD OR ANALYZER. ANALYZER WAS LOCATED IN A DRY LOCATION AT 71°F (21/22°C), ON A FLAT SURFACE. POWER CORD WAS CONNECTED TO A SURGE PROTECTOR. THERE WAS NO: VISIBLE SMOKE, EVIDENCE OF SMOKE, STATIC OR ELECTRIC SHOCK, CHARING, BURNT SMELL, SCORCH MARK OR FIRE. THERE WAS NO INJURY OR DEATH AS A RESULT OF THE SPARKING. THERE WAS NO DELAY OR IMPACT TO PATIENT TEST / TREATMENT, TEST WAS PERFORMED ON ANOTHER ANALYZER.

    Description of Event or Problem · 0

    CUSTOMER REPORT OF SPARKING FOR AFINION (B)(6) ANALYZER WHILE DOING A PATIENT TEST. SPARKING WAS SEEN BETWEEN THE POWER CORD AND THE ANALYSER, THE CUSTOMER WAS UNABLE TO SPECIFY IF SPARK WAS FROM POWER CORD OR ANALYZER. ANALYZER WAS LOCATED IN A DRY LOCATION AT 71°F (21/22°C), ON A FLAT SURFACE. POWER CORD WAS CONNECTED TO A SURGE PROTECTOR. THERE WAS NO: - VISIBLE SMOKE. - EVIDENCE OF SMOKE. - STATIC OR ELECTRIC SHOCK. - CHARING . - BURNT SMELL. - SCORCH MARK. - FIRE. THERE WAS NO INJURY OR DEATH AS A RESULT OF THE SPARKING. THERE WAS NO DELAY OR IMPACT TO PATIENT TEST / TREATMENT, TEST WAS PERFORMED ON ANOTHER ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551949 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1115175 10181741

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown