BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3905473 · Received July 1, 2014

    Report

    Report Number
    2939301-2014-16075
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 24, 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) ALLEGING HER ONE TOUCH ULTRA 2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. AT AN UNSPECIFIED DATE/TIME, THE PATIENT STATED SHE DEVELOPED SYMPTOMS OF ¿ITCHING¿. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON (B)(6) 2014 AT 8:00 A. M. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN), DIET, AND EXERCISED AND STATED SHE TOOK AN INCREASED DOSE OF MEDICATION (METFORMIN, 1000 MG) IN RESPONSE TO THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME ON (B)(6) 2014, THE PATIENT STATED HER BLOOD GLUCOSE WAS TESTED WITH AN EMS METER AND OBTAINED A READING OF ¿551 MG/DL¿. AT 8:00 A. M. THE PATIENT CLAIMED HER HEALTH CARE PROFESSIONAL (HCP) TREATED HER WITH ORAL MEDICATION (METFORMIN, 1000 MG). AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE PATIENT USED THE METER AND THERE WAS NO MISUSE OF THE PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384225 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3632940

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R