BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3233455 · Received July 18, 2013

    Report

    Report Number
    2183996-2013-01321
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 12, 2013
    Report Date
    September 25, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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 ALARM FUNCTIONS OF THE PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ADAPTER 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 USED RETURNED INFUSION 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.

    Description of Event or Problem · 1

    PATIENT REPORTED HER BLOOD GLUCOSE WAS 260 MG/DL WHEN SHE WOKE IN THE MORNING, AND IT INCREASED TO 400 MG/DL DESPITE DELIVERING INSULIN VIA THE INFUSION DEVICE. SHE CHANGED THE ACCESSORIES AND DELIVERED INSULIN VIA PEN, AND NOW HER BLOOD GLUCOSE IS UNDER CONTROL. SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333324 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR