BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3253537 · Received July 30, 2013

    Report

    Report Number
    3008382007-2013-21415
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (03/24/2014). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 3/11/2014 AND 3/13/2014, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 08/27/2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER WAS DIFFICULT DISPLAY WAS TOO DIFFICULT TO READ EVEN WITH THE BACKLIGHT AND WITH THE ADJUSTMENT OF THE CONTRAST FEATURE -BOX WHERE SHE ENTERS CARBOHYDRATE INFORMATION IS TOO SMALL AND THEREFORE SHE SOMETIMES ENTERS TOO MUCH CARBOHYDRATES AND SOMETIME TOO LITTLE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON AN UNKNOWN DATE/TIME. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH INSULIN THROUGH PUMP THERAPY AND SHE REPORTED THAT SHE INCREASED HER FOOD/DRINK CONSUMPTION IN RESPONSE TO THE ALLEGED ISSUE ON AN UNKNOWN DATE. THE PATIENT ALLEGED THAT ON AN UNKNOWN DATE/TIME, SHE DEVELOPED SYMPTOMS OF LOW SUGARS; DIZZINESS, SWEATING AND CONFUSION¿ WITHIN 1 HOUR AFTER EATING AND IMMEDIATELY SELF TREATED BY ADMINISTERING A GLUCAGON SHOT. SHE ALSO REPORTED SHE DEVELOPED HIGH BLOOD SUGAR SYMPTOM OF ¿DRY MOUTH¿ ON AN UNKNOWN DATE/TIME DUE TO THE ALLEGED ISSUE BUT DENIED RECEIVING MEDICAL INTERVENTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354615 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3454703

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R