BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4192231 · Received October 22, 2014

    Report

    Report Number
    2939301-2014-28323
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 15, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRA2 METER WAS TESTING IN SETTINGS MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED PRODUCT ISSUE FIRST OCCURRED ON (B)(6) 2014 ¿DURING THE NIGHT¿. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION AS WELL AS DIET AND/OR EXERCISE AND THEY DID NOT TAKE ANY ACTION IN RESPONSE TO THEIR REGULAR DIABETES MANAGEMENT REGIMEN ROUTINE AS A RESULT OF THE PRODUCT ISSUE. THE PATIENT STATED THAT ¿NOT LONG¿ AFTER THE PRODUCT ISSUE BEGAN THEY FELT ¿SWEATY¿. IN RESPONSE TO THIS THE PATIENT SELF-TREATED BY HAVING MORE FOOD/DRINK AT AROUND ¿NOON¿ ON (B)(6) 2014. AT THE TIME OF TROUBLESHOOTING THE CCA WALKED THROUGH THE CORRECT TESTING PROCEDURE WITH THE PATIENT AND THE ISSUE WAS RESOLVED. THE PRODUCTS WERE REQUESTED TO BE RETURNED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION(S): ALTHOUGH THE PRODUCT ISSUE WAS RESOLVED AT THE TIME OF TROUBLESHOOTING, THE PATIENT WAS UNABLE TO TEST THEIR BLOOD GLUCOSE ON THE SUBJECT METER WHICH LED TO THEM SUFFERING SYMPTOMS WHICH ARE SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673627 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3605020

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening