BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3863549 · Received June 10, 2014

    Report

    Report Number
    1823260-2014-04195
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED THE PUMP TURNED OFF IN THE MIDDLE OF THE NIGHT WITHOUT PROMPTING. CALLER STATED SHE DID NOT PUT THE PUMP INTO STOP MODE. CALLER REPORTED SHE FELT IT VIBRATE WHEN SHE WOKE UP AND FOUND THAT IT WAS IN STOP MODE. VERIFIED PUMP MY DATA SHOWS THE LAST ERROR MESSAGE ON PUMP WAS AN E2 BATTERY EMPTY AT 3:09 PM YESTERDAY. CALLER STATED SHE CHANGED THE BATTERY AT THAT TIME. CALLER REPORTED EXPERIENCING A BLOOD GLUCOSE LEVEL OF 240 MG/DL AT 6 AM; WAS ABLE TO SELF-TREAT BY GIVING 4 UNITS VIA PUMP AFTER SHE PUT IT BACK INTO RUN MODE. PATIENT'S NORMAL RANGE IS 130-170 MG/DL. PATIENT STATED THERE WAS NO ERROR MESSAGE. NO ADVERSE EVENT REPORTED. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338412 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1