BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2495494 · Received March 19, 2012

    Report

    Report Number
    2939301-2012-02669
    Event Type
    Injury
    Date Received
    March 19, 2012
    Report Date
    February 28, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. HOWEVER, THE PATIENT DID NOT RETURN THE TEST STRIPS AS REQUESTED. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THE TEST STRIPS AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS READING INACCURATELY HIGH COMPARED TO FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY 2 WEEKS AGO PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE READINGS "IN THE 200'S MG/DL" WITH THE SUBJECT METER. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON AN INSULIN PUMP. DUE TO THE ALLEGED HIGH READING, THE PATIENT CLAIMED SHE ADMINISTERED HERSELF INSULIN (TYPE/DOSE UNKNOWN). THE PATIENT STATED 10-15 MINUTES LATER, SHE DEVELOPED SYMPTOMS OF SHAKING AND SWEATING; WHICH SHE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO HER SYMPTOMS, THE PATIENT INDICATED SHE TREATED HERSELF WITH GLUCOSE TABLETS. ACCORDING TO THE PATIENT, NO OTHER BLOOD GLUCOSE DEVICE WAS USED AT THE TIME THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY; HOWEVER THE PATIENT WAS NOT ABLE TO PERFORM A QUALITY CONTROL SOLUTION TEST SINCE THE CONTROL SOLUTION WAS NOT AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT OF INSULIN BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R