BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3093575 · Received May 6, 2013

    Report

    Report Number
    2183996-2013-00795
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    December 11, 2012
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLIES WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    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

    PATIENT REPORTED SHE EXPERIENCED HYPERGLYCEMIA (UP TO "HI" MMOL/L) FOR 1 WEEK AROUND (B)(6) 2012. SHE DID NOT FEEL ILL AND DISCUSSED THIS WITH HER DIABETES NURSE. HER BLOOD GLUCOSE WAS TESTED AT THE HOSPITAL AND WAS APPROXIMATELY 40 MMOL/L (720 MG/DL). SHE WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS AND WAS TREATED WITH INSULIN UNTIL HER BLOOD GLUCOSE NORMALIZED. SHE DID NOT KNOW WHAT CAUSED HYPERGLYCEMIA AND REPORTED THERE WERE NO SIGNS OF OCCLUSIONS OR ERROR MESSAGES ON THE INFUSION DEVICE. SHE BEGAN TO DELIVER INSULIN VIA PEN BEFORE BEING DISCHARGED, AND SHE LEFT THE INFUSION DEVICE WITH HER DIABETES NURSE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197267 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR Hospitalization| R