BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1946353 · Received December 10, 2010

    Report

    Report Number
    2183996-2010-02601
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE INFUSION DEVICE DISPLAY WAS "COMPLETELY DARK." PT HAD DELIVERED A BOLUS AND WANTED TO REVIEW THE BOLUS HISTORY. SHE PRESSED THE WRONG BUTTON AND ACCIDENTLY RETRACTED THE PISTON ROD, AND THEN THE DISPLAY BECAME DARK AND THE INFUSION DEVICE WOULD NOT DO ANYTHING. PT WAS USING THE CORRECT TYPE OF BATTERY AND REPORTED IT WAS A COUPLE OF MONTHS OLD. SHE INSERTED A NEW BATTERY OF THE SAME TYPE, AND INFUSION DEVICE SUCCESSFULLY POWERED ON. VERIFIED BATTERY SETTING WAS PROGRAMMED CORRECTLY. ALARM HISTORY WAS VERIFIED, AND INFUSION DEVICE DID NOT GIVE LOW BATTERY ALERT (A2) OR BATTERY DEPLETED ERROR (E2). INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR INSULIN INFUSION SET| INSULIN