BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3221247 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01270
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    February 18, 2013
    Report Date
    September 10, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE PISTON ROD WAS NOT BLOCKED, AND THERE WERE NO E6 IN HISTORY. THE ADAPTER PASSED THE OPTICAL INSPECTION. THE BATTERY COVER PASSED THE OPTICAL INSPECTION. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE RETURNED TRANSFER SET WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS.

    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. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED HER BLOOD GLUCOSE ELEVATED TO 1000 MG/DL AROUND (B)(6) 2013, AND SHE WAS UNABLE TO WALK AND FELT VERY SICK. HER HUSBAND TOOK HER TO A DIABETES SPECIALIST, AND SHE RECEIVED AN INFUSION OF AN UNKNOWN MEDICATION. SHE WAS THEN TRANSPORTED TO THE HOSPITAL. SHE WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH DIABETIC KETOACIDOSIS, AND SHE WAS DISCHARGED ON (B)(6) 2013. THE DIABETES SPECIALIST BELIEVES THE PISTON ROD WAS BLOCKED AND THE INFUSION DEVICE DID NOT DELIVER INSULIN. SHE IS CURRENTLY RECEIVING INSULIN VIA PEN. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319790 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR Hospitalization| R