BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D/LINK

    MDR report key: 3251524 · Received July 29, 2013

    Report

    Report Number
    2183996-2013-01406
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKY AT THE HEADSET CANNOT BE VERIFIED, THE HEAD SETS MEET PRODUCT SPECIFICATIONS. RESULT THREE UNUSED RETURNED HEAD SETS WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ADDITIONALLY A CONNECTOR CLICK TEST HAS BEEN DONE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT INSULIN FROM THE INFUSION DEVICE IS NOT ABSORBING INTO HER SKIN AT HER INFUSION SET INSERTION SITE. PATIENT STATED SHE NOTICED MOISTURE AT THE INFUSION SITE AND EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL REACHED AS HIGH AS 27 MMOL/L (486 MG/DL) ON YESTERDAY; AND TODAY HER BLOOD GLUCOSE LEVEL WENT AS HIGH AS 25 MMOL/L (450 MG/DL). PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT STATED SHE BELIEVES THE INSULIN IS NOT ABSORBING INTO HER SKIN. PATIENT REPORTED SHE CHANGED TO A NEW INFUSION SET FROM THE SAME LOT BUT THE ISSUE PERSISTED (MOISTURE AT THE INFUSION SITE AND ELEVATED BLOOD GLUCOSE LEVEL). PATIENT STATED THE INFUSION SITES WERE ON OPPOSITE SIDES OF HER ABDOMEN. PATIENT REPORTED SHE WAS NOT SURE HOW LONG THE FIRST INFUSION SET HAD BEEN IN USE BUT THE 2ND INFUSION SET WAS IN USE LESS THAN ONE DAY. ADVISED TO TRY AN INFUSION SET FROM A DIFFERENT LOT. PATIENT STATED THE ISSUE WAS HAPPENING WITH THIS PARTICULAR LOT. PATIENT REPORTED SHE HAD NO CONCERNS WITH PREVIOUS BATCHES. PATIENT STATED SHE WILL SPEAK WITH HER DIABETES EDUCATOR REGARDING THE ISSUE. PATIENT IS CURRENTLY ON HER BACKUP PLAN; IS INJECTING AT THE MOMENT. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353427 ACCU-CHEK RAPID-D/LINK SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS, INC 00700006928 32435152

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR