BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2943283 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00028
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 3, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PUMP HISTORY THE TIME/DATE SETTINGS HAVE BEEN LOST AFTER RESTART OF THE PUMP/BATTERY CHANGE. THE ACID OF THE SUPERCAP HAS LEAKED OUT. THEREFORE, THE SUPERCAP AND THE SURROUNDING ELECTRONIC PARTS ARE CORRODED. THE SUPERCAP WAS NOT FUNCTIONING ANYMORE AND DID NOT PROVIDE ENERGY DURING THE BATTERY CHANGE TO KEEP THE DATE/TIME SETTING IN MEMORY. A SUPERCAP IS A CAPACITOR USED FOR PROVIDING ENERGY TO THE MEMORY INTEGRATED CIRCUIT TO KEEP THE DATE AND TIME SETTING FOR A WHILE, WHEN NO BATTERY IS IN THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PT'S BLOOD GLUCOSE LEVEL WAS 32.6 MMOL/L (586.8 MG/DL) AT 6:23 ON (B)(6) 2013. THE PT USED 60KH AND TOOK A BOLUS OF 18.4 UNITS OF INSULIN. AT 9:20 HIS BLOOD GLUCOSE LEVEL WAS 33.2 MMOL/L (597.6 MG/DL). AT 10:28 HIS BLOOD GLUCOSE LEVEL WAS 10.1 MMOL/L (181.8 MG/DL). THE PT'S MOTHER THINKS THE INFUSION DEVICE DID NOT DELIVER THE BOLUS AT 6:23, BUT INSTEAD DELIVERED IT AT 9:23. A TRAINER VISITED THE PT AND DID NOT FIND A BOLUS OF 18.4 UNITS OF INSULIN AT 6:23 IN THE INFUSION DEVICE'S HISTORY, BUT DID SEE IT IN THE HISTORY OF THE BLOOD GLUCOSE MONITOR. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28985 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP