BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2142930 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01825
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED HE WENT TO THE HOSPITAL ON (B)(6) 2011 DUE TO ELEVATED BLOOD GLUCOSE READING OF "HI" ON HIS BLOOD GLUCOSE MONITOR. HE STATED HE WAS TAKING 10 UNITS OF INSULIN EVERY HOUR IN AN ATTEMPT TO LOWER HIS BLOOD GLUCOSE. HIS BLOOD GLUCOSE MEASURED 320 MG/DL WHEN HE WAS TESTED AT THE HOSPITAL AT 3:13AM AND HE WAS GIVEN 20 UNITS AT HUMALOG. HE STATED HIS BLOOD GLUCOSE HAS BEEN ELEVATED FOR A COUPLE OF DAYS. TROUBLESHOOTING DID NOT REVEAL ANY PRODUCT ISSUES. THE PT'S WIFE TOOK OVER THE CALL AND STATED THE PT WAS DISORIENTED. HIS BLOOD GLUCOSE MEASURED 500 MG/DL PRIOR TO THE REPORT. PRIOR TO THE REPORT HE WAS ADVISED BY HIS PHYSICIAN TO CHANGE THE INFUSION TUBING AND TO PRIME. HIS NORMAL BLOOD GLUCOSE RANGE IS 80-200 MG/DL. UPON FOLLOW UP ON (B)(6) 2011, THE PT'S WIFE REPORTED HIS BLOOD GLUCOSE HAD DECREASED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP