BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2982022 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00200
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL ALARM FUNCTIONS WERE TESTED SUCCESSFUL AND NO MALFUNCTION COULD BE OBSERVED DURING THE TECHNICAL INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE AUDIO-SIGNAL ON THE INFUSION DEVICE IS DEFECTIVE. THE BEEP VOLUME WAS SET ON THE SECOND BAR AND WAS INCREASED TO THE MAXIMUM LEVEL. HE INITIATED THE CARTRIDGE CHANGE PROCESS AND WAS NOT ABLE TO HEAR THE BEEPS. HE INSERTED A NEW ALKALINE BATTERY. THE INFUSION DEVICE DID NOT PRODUCE ANY SOUND DURING THE BEEP TEST AND WAS VERY FAINT AT OTHER TIMES. IT WAS VERIFIED THE BEEP VOLUME WAS STILL SET TO THE MAXIMUM LEVEL. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55388 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES