BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 949215 · Received November 15, 2007

    Report

    Report Number
    2183996-2007-01693
    Event Type
    Injury
    Date Received
    November 15, 2007
    Date of Event
    October 30, 2007
    Report Date
    November 13, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K042887
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED, ERRATIC BLOOD GLUCOSE READINGS FROM 54-584 MG/DL WITH HER RECOMMENDED RANGE BEING 100-125 MG/DL. SHE STATED, HER ONLY SYMPTOM IS FREQUENT URINATION. SHE SAID, WHEN SHE TESTED HER BLOOD GLUCOSE IT WAS 584 MG/DL. SHE STATED, SHE BOLUSED 4 UNITS OF INSULIN THOUGH HER INSULIN INFUSION DEVICE, BUT HER BLOOD GLUCOSE DID NOT DECREASE. SHE SAID, SHE WAITED 2-3 HOURS AND BOLUSED 3 UNITS OF INSULIN AND THEN HER READING DROPPED TO 54 MG/DL. THE PT STATED, HER INFUSION DEVICE IS ALSO GIVING E3 (AUTOMATIC OFF) MESSAGES MORE FREQUENTLY. DURING TROUBLESHOOTING, THE PT STATED SHE CHANGES HER INFUSION SET EVERY 2-3 DAYS. SHE WAS ADVISED THAT RECOMMENDED USE OF HER INFUSION SET WAS NO MORE THAN 2 DAYS. THE PT SAID, SHE DOES NOT ALLOW INSULIN TO REACH ROOM TEMPERATURE BEFORE USING AND WAS ADVISED TO DO SO. THE PT STATED, SHE PREVIOUSLY REPORTED AN INSULIN LEAK IN HER CARTRIDGE COMPARTMENT AND SHE HAS HAD ERRATIC BLOOD GLUCOSE READINGS SINCE THAT TIME. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R INSULIN| INSULIN INFUSION SET