BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2083400 · Received April 28, 2011

    Report

    Report Number
    2183996-2011-01281
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    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

    ON (B)(6) 2011, PATIENT REPORTED SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011, WITH HIGH KETONES AND VERY HIGH BLOOD GLUCOSE LEVELS. PATIENT STATED THAT INFUSION DEVICE HAD BEEN GIVING E6 (MECHANICAL ERROR) MESSAGES ALL DAY. PATIENT REPORTED THIS HAD BEEN OCCURRING FOR THE PAST 2 WEEKS. PATIENT STATED WHEN THE E6 ERRORS WERE OCCURRING; SHE HAD BEEN REPLACING THE BATTERY TO GET RID OF THE E6 ERRORS. PATIENT REPORTED SHE WAS GIVING BOLUSES ALL DAY BUT HER BLOOD GLUCOSE LEVEL WAS STILL READING "HI". PATIENT STATED SHE ALSO NOTICED INSULIN LEAKING INTO THE CARTRIDGE CHAMBER. PATIENT REPORTED SHE TRIED TO WASH IT OUT BUT IT CONTINUED TO HAPPEN. PATIENT STATED CRYSTALS FORMED AROUND THE PISTON ROD. PATIENT REPORTED SHE HAS NOW BEEN DISCHARGED FROM THE HOSPITAL AND IS WELL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT STATED SHE WAS PUT ON A SLIDING SCALE TO GET HER BLOOD GLUCOSE LEVELS DOWN. PATIENT REPORTED SHE WAS IN THE HOSPITAL FROM (B)(6) 2011. PATIENT STATED HER LAST BLOOD LEVEL PRIOR TO THE INCIDENT WAS BETWEEN 7-15 MMOL/L (126-270 MG/DL); EXACT READING WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 Hospitalization| O| R INSULIN (DATE OF TX: (B)(6))| INSULIN INFUSION SET (DATE OF TX: (B)(6))