BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2755437 · Received September 19, 2012

    Report

    Report Number
    2183996-2012-01377
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    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 PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED SHE EXPERIENCED UNEXPECTED HYPERGLYCEMIA BEGINNING IN THE MORNING ON (B)(6) 2012. THE FOLLOWING BLOOD GLUCOSE LEVELS WERE PROVIDED FROM (B)(6) 2012: 289 MG/DL AT 8:00 AM, 296 MG/DL AT 11:30 AM, 336 MG/DL AT 12:45 PM, 391 MG/DL AT 2:45 PM, 340 MG/DL AT 6:20 PM, AND 355 MG/DL AT 8:30 PM. SHE DELIVERED INSULIN VIA THE INFUSION DEVICE AS A CORRECTION. THE FOLLOWING BLOOD GLUCOSE LEVELS WERE PROVIDED FROM (B)(6) 2012: 503 MG/DL AT 1:45 AM, 298 MG/DL AT 10:30 AM, AND 333 MG/DL AT 1:00 PM. A PUMP EDUCATOR CHECKED THE INFUSION DEVICE, AND IT APPEARED TO BE FUNCTIONING NORMALLY. SHE CHANGED THE INFUSION SET AND CARTRIDGE, BUT SHE CONTINUED TO EXPERIENCE ELEVATED BLOOD GLUCOSE AND FELT DIZZY. SHE CONTACTED HER DOCTOR AT 1:00 PM ON (B)(6) 2012 AND WAS ADVISED TO DISCONTINUE USE OF THE INFUSION DEVICE AND DELIVER INSULIN VIA PEN. HER DOCTOR ADVISED THE CAUSE OF HYPERGLYCEMIA WAS "COMPARISON OF PRODUCT MALFUNCTION." SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET AND INFUSION DEVICE WERE REPLACED AND REQUESTED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR INSULIN INFUSION PUMP| INSULIN| ACCESSORIES