BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4251510 · Received November 14, 2014

    Report

    Report Number
    1823260-2014-08937
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 19, 2014
    Report Date
    January 9, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    HOSPITAL STAFF REPORTED PATIENT HAS BEEN ADMITTED TO THE HOSPITAL FOR DKA ON (B)(6) 2014. CALLER STATED THE PATIENT HAD A READING OVER 800 ON THE HOSPITAL METER. PATIENT REPORTED SHE EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS BEGIN THE EVENING OF (B)(6) 2014. PATIENT PROGRAMMED A TEMPORARY BASAL RATE (TBR) OF 150%. PATIENT STATED ON MONDAY AT 2:30 AM, SHE BEGAN VOMITING AND ASKED HER HUSBAND TO TAKE HER TO THE HOSPITAL. PATIENT REPORTED SHE WAS GIVEN AN IV OF 3 BAGS OF SALINE AND IS ON AN INSULIN DRIP. PATIENT STATED SHE WAS ALSO GIVEN AN INJECTION FOR BLOOD CLOTS. PATIENT ALLEGES THE ELEVATED BLOOD GLUCOSE LEVEL IS DUE TO A LEAK IN THE SYSTEM. PATIENT REPORTED SHE DISCOVERED THE LEAK WHILE AT THE HOSPITAL DURING TROUBLESHOOTING. PATIENT STATED SHE HAD PROGRAMMED A BOLUS AND THE PUMP BEGAN TO LEAK AT THE LUER. PATIENT REPORTED SHE DRIED THE ADAPTER/LUER AND TIGHTENED THE TUBING, BUT INSULIN CONTINUED TO LEAK FROM THE LUER INSTEAD OF THE END OF THE TUBING; TUBING IS 2 WEEKS OLD, SO ADVISED PATIENT TO CHANGE TUBING EVERY 6 DAYS. PATIENT STATED SHE SMELLED INSULIN BEFORE THE HOSPITALIZATION BUT DID NOT INVESTIGATE TO SEE IF THERE WAS A LEAK. INFUSION SET NOT AVAILABLE; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737950 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR Hospitalization| R GABAPETIN| LEVOTHYROXINE| NOVOLOG U100| WELLBUTRIN