BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 15499832 · Received September 28, 2022

    Report

    Report Number
    3003045237-2022-00004
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    August 31, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOW CLOSED. CUSTOMER DID NOT RETURN INSTRUMENT / POWER PACK AS REQUESTED FOR INVESTIGATION. AS THE INSTRUMENT IS NOT AVAILABLE FOR, ASSIGNABLE CAUSE CANNOT BE DETERMINED. THE RISK OF HARM FROM FAILURES ASSOCIATED WITH THE REPORTED ISSUE IS ACCEPTABLE AND IS WITHIN THE PREDICTED OCCURRENCE RATE IN THE FMEA AND THE FAILURE RATE IS MONITORED BY TRACKING AND TRENDING. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT IS NOT RELATED TO PRODUCT RESULTS, INADEQUATE INSTRUCTIONS FOR USE OR INACCURATE LABELS. THEREFORE, IT DOES NOT REPRESENT A POTENTIAL FOR PRODUCT DEFICIENCY PER INTERNAL PROCEDURES. THE CONCLUSION IS SUPPORTED BY THE MONTHLY COMPLAINT PRODUCT TREND REPORT .

    Description of Event or Problem · 0

    THE CUSTOMER EMAILED TECHNICAL SERVICES (TS) TO REPORT AN ISSUE WITH THEIR AFINION AS100 (1116054) , S/N (B)(4). DETAILS OF THE ISSUE: SPARKING AND MAKING GRINDING NOISE. THE FOLLOWING WAS OBSERVED WITH THE ANALYZER: VISIBLE SMOKE, BURNT SMELL, AND INSTRUMENT BEING TOO WARM/HOT TO TOUCH. NO INFORMATION REGARDING THE POWER CORD COULD BE PROVIDED. STATED THAT THE SPARKING OCCURRED IN THE HATCH AND NOT IN THE CABLE. NO DEATH OR SERIOUS INJURY REPORTED, AND NO IMPACT OR DELAY IN ANY TREATMENT. NOTED THAT NO ONE GOT HURT. CUSTOMER NO LONGER WANTED TO SWITCH ON THE ANALYZER TO THE REPORTED ALLEGATIONS PER THE CUSTOMERS PROCURED TENDER/DISTRIBUTOR AGREEMENT OF IMMEDIATE SWAPS FOR RENTAL UNITS WITHOUT TROUBLESHOOTING, A RETURN AND REPLACEMENT IS TO BE ORGANIZED.

    Description of Event or Problem · 0

    THE CUSTOMER EMAILED TECHNICAL SERVICES (TS) TO REPORT AN ISSUE WITH THEIR AFINION AS100 (1116054) , S/N (B)(6). DETAILS OF THE ISSUE: SPARKING AND MAKING GRINDING NOISE. THE FOLLOWING WAS OBSERVED WITH THE ANALYZER: - VISIBLE SMOKE - BURNT SMELL - INSTRUMENT BEING WARM/HOT TOO TOUCH NO INFORMATION REGARDING THE POWER CORD COULD BE PROVIDED. STATED THAT THE SPARKING OCCURRED IN THE HATCH AND NOT IN THE CABLE. NO DEATH OR SERIOUS INJURY REPORTED, AND NO IMPACT OR DELAY IN ANY TREATMENT. NOTED THAT NO ONE GOT HURT. CUSTOMER NO LONGER WANTED TO SWITCH ON THE ANALYZER TO THE REPORTED ALLEGATIONS PER THE CUSTOMERS PROCURED TENDER/DISTRIBUTOR AGREEMENT OF IMMEDIATE SWAPS FOR RENTAL UNITS WITHOUT TROUBLESHOOTING, A RETURN AND REPLACEMENT IS TO BE ORGANIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633652 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116054 10200694

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown