BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® RAPID-D INFUSION SET

    MDR report key: 3042139 · Received April 9, 2013

    Report

    Report Number
    2183996-2013-00614
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    FRESENIUS KABI DEUTSCHLAND GMBH
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNUSED TRANSFER SET WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT ON (B)(6) 2013 AT 9:00PM HER BLOOD GLUCOSE LEVEL WAS 502 MG/DL AND SHE FELT COLD AND SICK. THE PATIENT'S DAUGHTER CAME TO HER HOUSE AND THEY CHANGED ALL THE ACCESSORIES ON THE INFUSION DEVICE. THEY TESTED HER BLOOD GLUCOSE LEVEL MULTIPLE TIMES AND IT RANGED FROM 497-590 MG/DL. ON (B)(6) 2013, THE PATIENT'S DAUGHTER CALLED FOR EMTS. WHEN THEY ARRIVED THEY TREATED THE PATIENT WITH AN IV. THE PATIENT DOES NOT KNOW WHAT WAS IN THE IV. AT 2:00AM ON (B)(6) 2013, THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS DISCONNECTED FROM THE INFUSION DEVICE WHEN SHE ARRIVED AT THE HOSPITAL AND SHE WAS PUT BACK ON THE DEVICE THURSDAY AFTERNOON TO VERIFY IT WAS WORKING PROPERLY. THE PATIENT HAS EXPERIENCED ADDITIONAL STRESS RECENTLY. TROUBLESHOOTING WITH THE PATIENT DID NOT IDENTIFY ANY PROBLEMS WITH THE INFUSION DEVICE OR ACCESSORIES. AFTER THE PATIENT CHANGED HER INFUSION SET AND WAS TREATED BY THE EMTS, HER BLOOD GLUCOSE LEVEL HAS STAYED BETWEEN 110 AND 130 MG/DL, BUT NO ALLEGATION WAS MADE AGAINST THE PERFORMANCE OF THE INFUSION SET IN USE DURING THE TIME OF THE EVENT. THE INFUSION SET AND ADAPTER WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147329 ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET FPA FRESENIUS KABI DEUTSCHLAND GMBH NA 32071292

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR Hospitalization| R HEARING AID| MULTI - VITAMIN| VESICARA| VITAMIN C| MAGNESIUM OXIDE| PRAVASTATIN| HUMALOG U100| CALCIUM 600 W/VITAMIN D| GLUCOSAMINE SULFATE