BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3103349 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00831
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 6, 2013
    Report Date
    July 2, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PATIENT DID NOT RETURN ANY PRODUCT FOR EVALUATION, AND THE RETENTION SAMPLE MEETS SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. REVIEW OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS OF RELEVANCE FOR LOT NUMBER 0230069.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED HE HAD EXPERIENCED INTERMITTENT HYPERGLYCEMIA FOR THE PAST FEW WEEKS, AND HE WAS HOSPITALIZED FROM (B)(6) 2013. HE WAS HAVING DIFFICULTY STANDING AND HIS BLOOD GLUCOSE WAS "HI" MG/DL, AND HE WENT TO HIS ENDOCRINOLOGIST ON (B)(6) 2013. HIS BLOOD GLUCOSE WAS TESTED VIA LAB, AND HE WAS CONTACTED ON (B)(6) 2013 AND TOLD HIS BLOOD GLUCOSE WAS ABOVE 1000 MG/DL. HE WENT TO THE EMERGENCY ROOM AND WAS TREATED WITH AN INSULIN AND SALINE IV. HE DISCONNECTED THE INFUSION DEVICE FOR 1 WEEK AND RESTARTED IT WITHOUT SPEAKING TO HIS ENDOCRINOLOGIST. HIS BLOOD GLUCOSE WAS "FINE" UNTIL THE DAY OF THE REPORT. HE BELIEVES THE INFUSION TUBING WAS KINKED AND THE CANNULA WASN'T FULLY INSERTED AND THAT THIS CAUSED HYPERGLYCEMIA. THE INFUSION SETS IN USE HAVE BEEN DISCARDED, AND NO PRODUCT WILL BE RETURNED FOR EVALUATION. FOLLOW-UP WAS COMPLETED ON (B)(6) 2013. HE CHANGED THE INFUSION SET, CARTRIDGE, AND BATTERY AND WAS ABLE TO BOLUS TO DECREASE HIS BLOOD GLUCOSE TO HIS NORMAL RANGE (70-300 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203902 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S NA 0230069

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR Hospitalization| R VITAMIN C| VITAMIN D3| TUMS| WELBUTRINE| LOVASTATIN| HUMALOG| GABAPENTIN| LOMOTIL| TAMSULSIN| IRON PILL| LEXAPRO| LEVOTHYROXIN| MULTIVITAMIN