BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 2985110 · Received March 1, 2013

    Report

    Report Number
    2183996-2013-00294
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    May 3, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR EVALUATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD FOR LOT # 0234016 WAS VERIFIED AND FOUND WITHIN SPECIFICATIONS. THE COMPLAINT DESCRIBING A BENT SOFT CANNULA CANNOT BE VERIFIED; THE INFUSION SET MEETS PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, MOTHER REPORTED TO A COMPANY REPRESENTATIVE THAT THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO HYPERGLYCEMIA. MOTHER THOUGHT THE PATIENT HAD THE FLU BUT ALSO DID NOT THINK THE INFUSION DEVICE WAS DELIVERING INSULIN. THE PATIENT WAS TAKEN OFF INFUSION DEVICE THERAPY. FOLLOW-UP WAS COMPLETED WITH MOTHER, AND SHE REPORTED THE INFUSION SET AND CARTRIDGE WERE CHANGED ON (B)(6) 2013. PATIENT WOKE ON (B)(6) 2013 WITH HYPERGLYCEMIA AND THE FOLLOWING READINGS WERE PROVIDED: 212, 536, 376, 335, 220, 181, 550, 246, AND 89 MG/DL. PATIENT WAS GIVEN INSULIN AND CONTINUED TO USE THE INFUSION DEVICE, AND HIS BLOOD GLUCOSE WOULD DECREASE AND THEN INCREASE AGAIN. HIS BLOOD GLUCOSE WAS 369 ON THE MORNING OF THE REPORT, AND HIS TARGET RANGE IS 80-150 MG/DL. HE WAS TAKEN TO THE EMERGENCY ROOM ON (B)(6) 2013 AND WAS TREATED WITH IV FLUIDS BUT NOT ADMITTED. HE WAS DIAGNOSED WITH THE FLU. MOTHER DOES NOT BELIEVE THERE IS A DELIVERY ISSUE AND WAS ASSISTED WITH RESTARTING THE INFUSION DEVICE. HE WAS GIVEN NEW MEDICATIONS THAT DO INCREASE HIS BLOOD GLUCOSE. ADDITIONAL FOLLOW-UP WAS COMPLETED ON (B)(6) 2013, AND MOTHER REPORTED THE INFUSION SET WAS CHANGED ON (B)(6) 2013 AND THE CANNULA WAS BENT. SHE BELIEVES INSULIN POOLED AT THE SITE AND THIS CONTRIBUTED TO HYPERGLYCEMIA. THE HEADSET IS INSERTED WITH AN INSERTION DEVICE. HIS BLOOD GLUCOSE HAS RETURNED TO NORMAL SINCE THE HEADSET WAS CHANGED, AND HIS LAST READING WAS 127 MG/DL. THE ALLEGED INFUSION SET WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. PATIENT WAS SENT REPLACEMENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90067 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. NA 0234016

    Patients

    Seq Age Sex Outcome Treatment
    1 005 YR Hospitalization| R INSULIN