BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2905852 · Received January 9, 2013

    Report

    Report Number
    3008382007-2013-00560
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP: ((B)(4) 2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE ERROR COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING HIS WIFE'S ONETOUCH PING METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO 2 DOCTOR'S METERS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER ALLEGED THE ISSUE FIRST OCCURRED ON (B)(6) 2013 BETWEEN 2 AND 3PM. THE REPORTER ALLEGED THE PATIENT OBTAINED A READING OF '104MG/DL' ON THE LFS METER. THE REPORTER STATED THE PATIENT USES INSULIN PUMP THERAPY TO MANAGE HER DIABETES. THE REPORTER STATED THE PATIENT TOOK HER USUAL DOSAGE OF INSULIN IN ACCORDANCE WITH THE READING OBTAINED ON (B)(6) 2012 BETWEEN 2 AND 3PM. THE REPORTER STATED ON (B)(6) 2012 BETWEEN 2 AND 3PM, THE PATIENT DEVELOPED SYMPTOMS OF 'SHAKY, SWEATING, CRYING, AND ACTING SILLY.' THE REPORTER STATED THE PATIENT SELF ADMINISTERED GLUCOSE TABLETS OR GEL ON (B)(6) 2012 BETWEEN 2 AND 3PM. THE REPORTER STATED ON (B)(6) 2013 AT 10:30AM, THE PATIENT WAS SEEN IN A DOCTOR'S OFFICE AND HER BLOOD GLUCOSE WAS MEASURED ON 2 DIFFERENT CONTOUR METERS AND READINGS OF '82MG/DL' WERE OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT SELF ADMINISTERED TOO MUCH INSULIN, DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT. THERE IS NO INDICATION THAT THE METER MALFUNCTIONED SINCE THE TIME ELAPSED BETWEEN THE READINGS DOES NOT MEET LFS' CRITERIA FOR ACCURACY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11550 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3390760

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R