BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 2421439 · Received January 12, 2012

    Report

    Report Number
    2183996-2012-00042
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 4, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, REGIONAL CLINICAL SPECIALIST (RCS) REPORTED THE PT IS CURRENTLY IN A MEDICALLY INDUCED COMA IN THE HOSP. RCS STATED THE NURSE THAT REMOVED THE INFUSION DEVICE REPORTED THE INFUSION SET CANNULA WAS BENT. RCS REPORTED THE PT'S COMA IS DUE TO ELEVATED BLOOD GLUCOSE LEVELS AND HER BLOOD GLUCOSE LEVEL WAS 1300 MG/DL WHEN SHE ARRIVED AT THE HOSP. RCS STATED THE PT'S HUSBAND FOUND HER UNCONSCIOUS AT HOME AND TOOK HER TO THE HOSP. RCS REPORTED THE PT WAS ADMITTED TO THE HOSP ON (B)(6) 2012. PT'S NORMAL BLOOD GLUCOSE RANGE IS UNK. RCS STATED PRIOR TO GOING TO THE HOSP, THE INFUSION DEVICE WAS CONTROLLING THE PT'S BLOOD GLUCOSE LEVEL. ON CALL BACK PT'S HUSBAND REPORTED SHE IS ON A RESPIRATOR AND ANTIBIOTICS. HUSBAND STATED THEY ARE ALSO GIVING HER INSULIN AND HER BLOOD GLUCOSE LEVEL IS COMING DOWN SLOWLY. HUSBAND REPORTED THE DOCTORS THINK THE PT HAD A SLIGHT HEART ATTACK. HUSBAND STATED PT IS INSERTING THE INFUSION SETS BY HAND AND THE SET WAS IN USE FOR 5 DAYS. ADVISED NOT TO USE INFUSION SETS PAST 3 DAYS. HUSBAND REPORTED THE INSULIN CARTRIDGE AND TUBING WERE IN FOR 5 DAYS AS WELL. HUSBAND STATED THIS WAS HER FIRST CARTRIDGE AND INFUSION SET EVER USED. HUSBAND REPORTED THE INFUSION DEVICE DID NOT DISPLAY ERROR MESSAGES. HUSBAND STATED THE INSULIN CARTRIDGE WAS CLOSE TO GETTING EMPTY. HUSBAND REPORTED THE PT CHECKS HER BLOOD GLUCOSE 3-5 TIMES A DAY AND THEY WERE NORMAL PRIOR TO THE INCIDENT. ADVISED WILL SET UP A MEETING WITH A TRAINER UPON PT'S DISCHARGE FROM THE HOSP. ON F/U CALL ON (B)(6) 2012 HUSBAND DECLINED TO PROVIDE ANY ADD'L INFO. REQUESTED RETURN OF THE ALLEGED INFUSION SET AND INFUSION DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 7490382

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP