BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 2427994 · Received December 22, 2011

    Report

    Report Number
    2183996-2011-03063
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    December 13, 2011
    Report Date
    December 20, 2011
    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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. HE CHANGED THE INFUSION NEEDLE AND TRANSFER SET ON (B)(6) 2011. BLOOD GLUCOSE WAS BETWEEN 70 MG/DL-205 MG/DL ON (B)(6) 2011 AND 103-337 MG/DL ON (B)(6) 2011 DESPITE BOLUSING VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS BETWEEN 107-340 MG/DL ON (B)(6) 2011, AND PT DELIVERED INSULIN VIA THE INFUSION DEVICE. BLOOD GLUCOSE THEN ELEVATED TO 400 MG/DL AT 8:30 P.M., AND HE DELIVERED INSULIN VIA PEN AND CHANGED THE INFUSION SET AND ADAPTER. BLOOD GLUCOSE WAS 243 MG/DL AT 10:30 P.M., AND HE DELIVERED INSULIN VIA PEN AND EXERCISED FOR 10 MINS ON A BIKE. BLOOD GLUCOSE WAS BETWEEN 51-304 MG/DL ON (B)(6) 2011, AND HE DELIVERED INSULIN VIA THE INFUSION DEVICE AND CHANGED THE ADAPTER AND THE INFUSION SET. BLOOD GLUCOSE WAS 368 MG/DL AT 12:45 P.M., AND HE DELIVERED INSULIN VIA A PEN. PT CHECKED THE INFUSION DEVICE AT 2:00 P.M. AND NOTICED THE "PUMP DIDN'T SUPPLY INSULIN." PT CHANGES THE INFUSION NEEDLE EVERY 2-3 DAYS AND THE CARTRIDGE AND INFUSION TUBE EVERY 5-6 DAYS, AND HE WAS REFERRED TO THE USER'S GUIDE. PT DID NOT HAVE AN INFECTION OR START NEW MEDICATION, AND HIS NORMAL BLOOD GLUCOSE LEVEL IS 130-140 MG/DL. THE INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK D-TRONPLUS LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR PUMP USER FOR 10 YEARS| INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES