BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D

    MDR report key: 2971663 · Received January 30, 2013

    Report

    Report Number
    2183996-2013-00124
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED FOR EVALUATION ON (B)(4) 2013. THE COMPLAINT DESCRIBING A LEAK AT THE LUER CANNOT BE VERIFIED; THE MATERIAL MEETS PRODUCT SPECIFICATIONS. THE USED RETURNED SAMPLE WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS, AND THE DIMENSIONAL ACCURACY OF THE LUER WAS TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. THE CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. THE ADAPTER AND THE BATTERY COVER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT HAD CALLED FOR ASSISTANCE IN CHANGING HER INSULIN CARTRIDGE. AFTER CHANGING THE CARTRIDGE, 25 UNITS OF INSULIN WERE PRIMED, BUT NO INSULIN DRIPPED FROM THE END OF THE INFUSION TUBING. THE PT NOTICED MOISTURE AROUND THE LUER LOCK NEAR THE ADAPTER. SHE REMOVED THE CARTRIDGE FROM THE INFUSION DEVICE AND FOUND THAT INSULIN HAD SPILLED INSIDE THE DEVICE. THE PT POURED THE INSULIN OUT OF THE DEVICE AND DRIED THE REMAINING INSULIN WITH A TISSUE. THE PT INSERTED A NEW CARTRIDGE INTO THE DEVICE AND INSULIN DID DRIP FROM THE END OF THE TUBING WHILE PRIMING. THE PT BELIEVES THAT THE INFUSION TUBING WAS THE SOURCE OF THE LEAK. THE PT'S BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED FROM 130-291 MG/DL AND HER NORMAL RANGE IS 110-120 MG/DL. THE PT STATED THAT SHE HAD SEEN A LARGE AIR BUBBLE IN THE INFUSION TUBING THAT WAS NOT THERE WHEN SHE INSERTED THE INSULIN CARTRIDGE. FOLLOW-UP WITH THE PT REVEALED THAT HER BLOOD GLUCOSE LEVEL HAD RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED. THE INFUSION DEVICE, ADAPTER, INSULIN CARTRIDGE, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41955 ACCU-CHEK RAPID-D FPA ROCHE HEALTH SOLUTIONS INC. NA 32051182

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR ACCESSORIES| INSULIN INFUSION PUMP| INSULIN