BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 4171689 · Received October 15, 2014

    Report

    Report Number
    2939301-2014-27432
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT AN UNKNOWN TIME IN THE AFTERNOON. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN THROUGH PUMP THERAPY AND SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. ALTHOUGH THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE, SHE REPORTED BEING HOSPITALIZED ON (B)(6) 2014 AT AN UNKNOWN TIME. THE PATIENT WAS REPORTEDLY TESTED AT THE HOSPITAL AND OBTAINED A READING OF ¿300 MG/DL¿ ON AN UNKNOWN BRAND METER. THE PATIENT WAS TREATED BY A HEALTHCARE PROFESSIONAL WITH INSULIN. IT IS NOT KNOWN HOW LONG THE PATIENT WAS IN THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655183 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3640351

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening| R