BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3093527 · Received May 6, 2013

    Report

    Report Number
    2183996-2013-00792
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 28, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. E8 POWER INTERRUPT ERRORS WERE FOUND IN THE HISTORY LIST. THE BATTERY SPRING IS BROKEN. THE EXACT REASON FOR THIS IS UNKNOWN. DUE TO THIS, THE CONTACT TO THE POWER SOURCE WAS INTERRUPTED AND THE PUMP CANNOT BE STARTED. AN EXTERNAL MECHANICAL INFLUENCE HAS DAMAGED THE SLOT OF THE BATTERY COVER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(4) 2013, A PATIENT REPORTED THAT SHE ATTEMPTED TO BOLUS AND HER PUMP DID NOT BEEP OR VIBRATE UPON BUTTON PRESS; THE SCREEN WAS BLANK AND THE PUMP WAS NOT ON. THERE WERE NO ERROR MESSAGES. THE PATIENT WAS UNSURE WHEN HER PUMP HAD LAST WORKED AS SHE HAD NOT LOOKED AT THE SCREEN SINCE (B)(6) 2013. THE PATIENT INDICATED THAT UPON INSERTION OF A NEW BATTERY IN ATTEMPT TO GAIN PUMP POWER, THE SPRING THAT HOLDS THE BATTERY IN THE PUMP FELL OUT. TROUBLESHOOTING DID NOT REVEAL ANY IMPROPER HANDLING OF THE DEVICE BY THE PATIENT. NO OUTSIDE INTERVENTION OR ADVERSE EVENT WAS INDICATED. THE PUMP, BATTERY COVER, AND BATTERY HAVE BEEN REQUESTED FOR FURTHER EVALUATION DUE TO NO ALERT OR ERROR MESSAGE BEING PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197233 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR CPAP MACHINE| HUMALOG