BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2970398 · Received February 20, 2013

    Report

    Report Number
    2183996-2013-00219
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 1, 2007
    Report Date
    March 7, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. IT WAS UNKNOWN IF THE PATIENT USED ANY CONCOMITANT MEDICAL PRODUCTS. NO PRODUCT WAS AVAILABLE TO BE RETURNED.

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE S/N IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT SHE THINKS HER INFUSION DEVICE DELIVERS TOO MUCH INSULIN WHEN SHE USES REGULAR (B)(6) "FLASHLIGHT BATTERIES". SHE STATED THAT THE BATTERIES PROVIDE TOO MUCH POWER DURING THE FIRST 72 HOURS OF USE WHICH CAUSES THE INFUSION DEVICE TO DELIVER MORE INSULIN THAN IT SHOULD. SHE STATED THAT THIS CAUSED HER BLOOD GLUCOSE TO GO INTO THE 40'S MG/DL. SHE HAS BEEN ABLE TO BRING HER BLOOD GLUCOSE LEVEL BACK UP BY EATING A GRANOLA BAR AND DRINKING MILK. HER NORMAL BLOOD GLUCOSE RANGE IS 60-225 MG/DL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PATIENT NO LONGER HAS THAT INFUSION DEVICE. THEREFORE, NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74845 ACCU-CHEK SPIRIT INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR