BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3080917 · Received April 26, 2013

    Report

    Report Number
    2183996-2013-00748
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 21, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLIES WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, FATHER REPORTED THE BUTTONS ON THE INFUSION DEVICE WOULD NOT RESPOND TO PRESS. PATIENT'S BLOOD GLUCOSE WAS 373 MG/DL AND HIS NORMAL READING IS NEAR 150 MG/DL, AND HE WAS UNABLE TO DELIVER A BOLUS AS TREATMENT. HE INSERTED A NEW BATTERY, AND THE INFUSION DEVICE DISPLAYED AN E8 POWER INTERRUPT ERROR. HE WAS UNABLE TO CLEAR THE ERROR MESSAGE DUE TO THE NON-FUNCTIONAL BUTTONS. THE INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE, AND THE KEY-LOCK FEATURE WAS NOT ACTIVATED. FATHER REPORTED HE WOULD CONTACT HIS PHYSICIAN FOR AN INJECTION THERAPY PRESCRIPTION. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183120 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR COCHLEAR EAR INPLANT| HUMALOG