BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1993377 · Received January 21, 2011

    Report

    Report Number
    2183996-2011-00043
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE PAST 2 TIMES HER INFUSION DEVICE WAS AT 20.0 UNITS OF INSULIN, IT GAVE AN A2 (BATTERY LOW) ERROR MESSAGE ALERT INSTEAD OF AN A1 (CARTRIDGE LOW) ERROR MESSAGE ALERT. PATIENT STATED SHE RECEIVED THE A2 ERROR MESSAGE AND THEN CHECKED AND HER INSULIN CARTRIDGE WAS AT 20.0 UNITS OF INSULIN. PATIENT STATED SHE NEVER RECEIVED THE A1 ERROR MESSAGE. HAD PATIENT CHECK THE ERROR MEMORY. PATIENT REPORTED THERE WAS AN A1 (CARTRIDGE LOW) ERROR MESSAGE. PATIENT STATED WHEN IT CAME UP ON THE DISPLAY SCREEN, IT SAID 'BATTERY LOW'. PATIENT REPORTED SHE DOESN'T RECALL GETTING THIS ERROR ON (B)(6) 2011. HAD PATIENT CHECK THE ERROR MEMORY BACK FURTHER; FOUND THE A2 ERROR MESSAGES AS WELL. PATIENT REPORTED WITH THE FIRST A2 ERROR MESSAGE, THERE WAS NEVER AN A1 ERROR MESSAGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    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 INSULIN INFUSION SET| INSULIN