BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D/LINK

    MDR report key: 3093340 · Received May 6, 2013

    Report

    Report Number
    2183996-2013-00789
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    May 3, 2013
    Report Date
    July 11, 2013
    Manufacturer
    FRESENIUS KABI DEUTSCHLAND GMBH
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 CAN NOT BE VERIFIED. RESULT SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE THE COMPLAINT CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED HER SON WAS PLAYING OUTSIDE AND WHEN HE CAME BACK HIS BLOOD GLUCOSE LEVEL WAS 180 MG/DL WHICH WAS TOO HIGH FOR HIM. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. MOTHER STATED SHE SAW THE INFUSION SET TUBING WAS TORN OFF FROM THE LUER. MOTHER REPORTED THE SON STATED HE DOES NOT KNOW WHY. MOTHER DISCARDED THE ALLEGED INFUSION SET. MOTHER STATED THE PATIENT DID NOT NEED OUTSIDE ASSISTANCE. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196125 ACCU-CHEK RAPID-D/LINK INSULIN INFUSION SET FPA FRESENIUS KABI DEUTSCHLAND GMBH 00700006933 NA

    Patients

    Seq Age Sex Outcome Treatment
    1