BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3221249 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01273
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 9, 2013
    Report Date
    August 21, 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 SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. E4 ERRORS WERE FOUND IN THE HISTORY, AND THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. 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 ADAPTER PASSED THE OPTICAL INSPECTION.

    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 458 MG/DL AT 9:45 AM ON (B)(6) 2013. SHE CHANGED THE INFUSION SET AND CARTRIDGE, AND SHE DELIVERED 10 I.E. OF INSULIN VIA THE INFUSION DEVICE AND 8 I.E. VIA PEN. HER BLOOD GLUCOSE WAS 88 MG/DL AT 9:30 PM AND SHE WENT TO BED. SHE WOKE UP AND FELT SICK AT 2:00 AM ON (B)(6) 2013. HER BLOOD GLUCOSE WAS 356 MG/DL AND SHE HAD A KETONE MEASUREMENT OF "+++." SHE CHANGED THE INFUSION SET AND CARTRIDGE AGAIN AND DELIVERED INSULIN VIA THE INFUSION DEVICE. SHE BELIEVES THE INSULIN DELIVERY IS TOO LOW, AND 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
    320147 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR