BEUDAMED
    FDA Adverse Event Summary report: N

    OT PING METER

    MDR report key: 3851819 · Received June 5, 2014

    Report

    Report Number
    2939301-2014-13485
    Date Received
    June 5, 2014
    Report Date
    May 29, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH PING METER HAS A POWER ISSUE (DOES NOT TURN). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE POWER ISSUE BEGAN (B)(6) 2014. THE PATIENT MANAGED HIS DIABETES WITH THE INSULIN PUMP. AT THE TIME OF THE REPORTED ISSUE, THE PATIENT DID NOT TAKE ANY ACTION IN REGARDS TO HIS DIABETES MANAGEMENT. HE REPORTEDLY HAD INSOMNIA DURING THE SAME TIME. THERE WAS NO REPORT OF ANY REQUIRED HCP TREATMENT TO SUGGEST ACUTE COMPLICATION OF DIABETES. THE POWER ISSUE WAS NOT RESOLVED WITH TRAINING. THE METER DID NOT POWER ON WITH THE POWER BUTTON AND THE INSERTION OF THE TEST STRIP. THE LFS PRODUCT WAS REPLACED AND REQUESTED BACK TO LFS FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329170 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR