BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3132175 · Received May 29, 2013

    Report

    Report Number
    2183996-2013-00915
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 13, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4): NO PRODUCT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT AVAILABLE TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT HE HAD ELEVATED BLOOD GLUCOSE LEVELS RANGING FROM 309 TO 549 MG/DL STARTING ON (B)(6) 2013. HE NOTICED THAT HIS SHIRT WAS WET AT HIS INFUSION SITE AND CHANGED THE INFUSION SET AFTER HE GOT HOME FROM WORK. HIS TARGET BLOOD GLUCOSE RANGE IS 100 TO 120 MG/DL. THE PATIENT THINKS HE INSERTED THE INFUSION SET INCORRECTLY CAUSING THE INFUSION SET TO MALFUNCTION. HE IS NOT SURE IF THE LEAK CAME FROM THE CANNULA OR HIS INFUSION SITE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS DISCARDED. THEREFORE, NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235037 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR LEVOTHYROXINE| LISINOPRIL| LIALDA| MELOXICAM| NOVOLOG U100| ATORVASTATIN| TRAMADOL| HYDROXYCHLOROQUINE| TERBINAFINE| LEVOTHYROXINE| AVIVA METER| LITHIUM| ESTER C| PRAMIPEXOLE