BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1023260 · Received March 31, 2008

    Report

    Report Number
    2183996-2008-00423
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 26, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT'S MOTHER REPORTED THAT ON NINE DAYS EARLIER, THE PT'S BLOOD GLUCOSE MEASURED "HI" ON HIS BLOOD GLUCOSE MONITOR FROM 5:30 PM - 12:30AM. SHE STATED THE PT WAS "VERY ILL, THROWING UP". THE PT CHANGED HIS INFUSION SET AND INFUSION SITE LOCATION 3 TIMES DURING THAT PERIOD. AT 12:00 AM THE PT'S BLOOD GLUCOSE MEASURED 27 MMOL/L (486 MG/DL) AND HE INJECTED 27 UNITS OF INSULIN. HIS NORMAL BLOOD GLUCOSE RANGE IS 8-12 MMOL/L (144-216 MG/DL). UPON FOLLOW UP ON ONE DAY AFTER THE ORIGINAL DATE, THE PT REPORTED THAT HIS BLOOD GLUCOSE RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PT DID NOT RETAIN THE ALLEGED INFUSION SETS. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 5J130UF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN| INSULIN INFUSION PUMP