BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1421139 · Received July 24, 2009

    Report

    Report Number
    2183996-2009-01556
    Event Type
    Injury
    Date Received
    July 24, 2009
    Date of Event
    June 26, 2009
    Report Date
    June 26, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2009, THE PATIENT REPORTED THAT THIS MORNING HIS BLOOD GLUCOSE RANGED FROM 9-23.1 MMOL/L (162-416 MG/DL). HIS NORMAL BLOOD GLUCOSE RANGE IS 4-10 MMOL/L (72-180 MG/DL). HE STATED THAT HE HAS A SORE THROAT AND CONGESTION AND HE IS TAKING ANTIBIOTICS. THE PATIENT THEN FOUND THAT HIS INFUSION TUBING HAD BECOME DISCONNECTED FROM HIS INFUSION DEVICE. HE RECONNECTED THE INFUSION TUBING AND BOLUSED TO REMOVE AIR FROM THE SYSTEM. HE CHANGED HIS INFUSION SITE, RECONNECTED, AND BOLUSED 10 UNITS OF INSULIN TO LOWER HIS BLOOD GLUCOSE. UPON FOLLOW UP AT ABOUT 4 DAYS LATER, THE PATIENT STATED THAT HIS BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 163357

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention INSULIN INFUSION PUMP| INSULIN