BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2307856 · Received September 23, 2011

    Report

    Report Number
    2183996-2011-02499
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 16, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE PATIENT REPORTED HER INFUSION DEVICE "WAS NOT WORKING" AND NO INSULIN WAS BEING DELIVERED. SHE STATED NO ERROR MESSAGES WERE DISPLAYED ON THE INFUSION DEVICE. SHE STATED, SHE WAS ON HER WAY TO THE HOSPITAL AND DID NOT PROVIDE ANY FURTHER INFORMATION. UPON FOLLOW UP, THE PATIENT STATED, HER BLOOD GLUCOSE MEASURED 6.1 MMOL/L (110 MG/DL) AND SHE WAS GOING TO DRINK COFFEE AND SHE DELIVERED A BOLUS. SHE PROGRAMMED THE BOLUS ON THE BLOOD GLUCOSE METER AND "OK" WAS DISPLAYED AND SHE ASSUMED TO THE BOLUS HAD BEEN DELIVERED THROUGH THE INFUSION DEVICE. SHE STATED, THE INFUSION DEVICE DID NOT COUNT DOWN AND SHE DID NOT HEAR IT "CLICKING." SHE WENT TO LUNCH AND WENT SHOPPING AND PROGRAMMED A BOLUS USING THE BLOOD GLUCOSE METER AND "OK" WAS DISPLAYED. SHE HELD THE INFUSION DEVICE TO HER EAR AND COULD NOT HEAR THE DEVICE "CLICKING." TWO HOURS LATER, HER BLOOD GLUCOSE MEASURED 14.6 MMOL/L (263 MG/DL) AND HER DOCTOR ADVISED HER TO GO TO THE HOSPITAL. SHE ARRIVED AT THE DIABETES CENTER AT 3:45 PM ON (B)(6) 2011 AND SHE BOLUSED THREE UNITS OF NOVARAPID INSULIN. HER BLOOD GLUCOSE MEASURED 18.8 MMOL/L (338 MG/DL) AND HER KETONES WERE 1.3 MMOL/L. SHE WAS ADVISED TO DRINK WATER. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL AND DID NOT RECEIVE EMERGENCY TREATMENT. SHE LEFT THE DIABETES CENTER AT 5-6:00 PM. HER CURRENT BLOOD GLUCOSE RESULTS ARE BETWEEN 9-11 MMOL/L (162-198 MG/DL). THESE RESULTS ARE STILL HIGHER THAN USUAL AS HER TARGET RANGE IS AROUND 6 MMOL/L (108 MG/DL). AFTER LEAVING THE DIABETES CENTER, SHE MANAGED TO PERFORM A CORRECTION BOLUS THROUGH THE METER. SHE STATED THAT THE INFUSION DEVICE WAS DEFINITELY DELIVERING INSULIN AT THIS TIME. THE NEXT MORNING (B)(6) 2011, HER RESULT WAS 14.6 MMOL/L (263 MG/DL). SHE DID NOTICE AT SOME TIME THAT MORNING SHE SAW AN ERROR ON HER METER SAYING SOMETHING ABOUT BLUETOOTH NOT CONNECTING. SHE CALLED HER DIABETES EDUCATOR WHO THEN ORGANIZED TO SEND HER A REPLACEMENT METER AND INFUSION DEVICE. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 22 YR INSULIN:| INSULIN INFUSION SET: