BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2070232 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01078
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MOTHER REPORTED THAT THE INSULIN HAS "DISAPPEARED" FROM THE CARTRIDGE ON 3 OCCASIONS. THE INFUSION DEVICE PISTON ROD HAS BEEN HALF-WAY UP THE CARTRIDGE COMPARTMENT, BUT THE CARTRIDGE HAS BEEN EMPTY. PT WAS HOSPITALIZED IN (B)(6) 2011 DUE TO THIS. DESPITE FILLING THE CARTRIDGE CORRECTLY, THE CARTRIDGE WAS "COMPLETELY DRY" AFTER IT HAD BEEN IN USE FOR 2 DAYS. BLOOD GLUCOSE WAS "HI." PT WAS KEPT IN THE HOSPITAL FOR 1 DAY, AND PHYSICIAN SUPERVISED TREATMENT OF HYPERGLYCEMIA. PT "PASSED OUT" AS A CORRECTION BOLUS WAS GIVEN VIA THE INFUSION DEVICE. PT "CAME ROUND" IN THE EARLY EVENING AND DELIVERED INSULIN VIA PEN TO DECREASE BLOOD GLUCOSE. PT HAD KETONES OF 4-5. BLOOD GLUCOSE WAS APPROX 10/13 MMOL/L (180-234 MG/DL) PRIOR TO THE EVENT. THE OTHER 2 OCCASIONS WERE IN (B)(6) 2011 AND ON (B)(6) 2011. INFUSION DEVICE AND CARTRIDGE WERE REQUESTED FOR EVALUATION. INFUSION DEVICE WAS REPLACED. ADDITIONAL DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN INFUSION SET| INSULIN