BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2943280 · Received January 21, 2013

    Report

    Report Number
    2183996-2012-02108
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 25, 2012
    Report Date
    March 28, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. E10 (CARTRIDGE) ERROR WERE FOUND IN THE HISTORY. THE PUMP CORRECTLY TRIGGERED THE E10 ERROR MESSAGES DUE TO TEMPORARY STEP LOSS. THIS CAN BE CAUSED BY TOO HIGH FRICTION AND/OR INSUFFICIENT SUPPLY (DEPLETED OR INAPPROPRIATE BATTERY).

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT'S WIFE REPORTED THE PISTON ROD ON THE INFUSION DEVICE STOPPED DURING REWIND AND THE DEVICE SHUT OFF. WIFE STATED DURING THE CARTRIDGE CHANGE PROCESS, THE PISTON ROD REWOUND TO HALF-WAY AND SOUNDED LIKE A LOUD DYING MOTOR SOUND. WIFE REPORTED THE PISTON ROD ON THE INFUSION DEVICE STOPPED AND THE DEVICE DISPLAY WENT BLANK. WIFE STATED THERE WERE NO OTHER SOUNDS THAT COULD BE HEARD FROM THE DEVICE AFTER THE DISPLAY WENT BLANK. WIFE REPORTED THE BATTERY HAD BEEN IN THE INFUSION DEVICE FOR ABOUT A WEEK WHEN THE ISSUE OCCURRED. WIFE STATED THEY CHANGED THE BATTERY AND THE BATTERY COVER; SAME ISSUE OCCURS WHEN TRYING TO REWIND THE PISTON ON THE INFUSION DEVICE. WIFE REPORTED WHEN PUTTING A NEW BATTERY INTO THE INFUSION DEVICE, THE DEVICE DISPLAYED THE SELF-TEST SCREENS AND THEN DISPLAYED STOP. HAD WIFE CHECK THE INFUSION DEVICE ALARM HISTORY; ONLY A CARTRIDGE ERROR MESSAGE DISPLAYED YESTERDAY. WIFE STATED THE LAST BATTERY DEPLETED ERROR MESSAGE OCCURRED ON (B)(6) 2012. WIFE REPORTED THE CARTRIDGE NO INSULIN SPILLED INSIDE OF THE INFUSION DEVICE. ASSISTED WITH SETTING THE BACKUP INFUSION DEVICE'S BASAL RATES, TIME AND DATE SETTINGS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, BATTERY AND BATTERY COVER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28984 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN