BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2496825 · Received March 20, 2012

    Report

    Report Number
    2939301-2012-02732
    Event Type
    Injury
    Date Received
    March 20, 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

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A PRODUCT USABILITY ISSUE WITH HER ONETOUCH PING METER. DUE TO HER EYESIGHT, THE PATIENT STATED SHE IS UNABLE TO SEE THE CARBOHYDRATE COUNTER DISPLAY VERY WELL; HOWEVER SHE IS ABLE TO SEE HER RESULTS JUST FINE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE STARTED ON AN UNSPECIFIED DATE/TIME. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT STATED SHE IN ON AN INSULIN PUMP. DESPITE THE ALLEGED ISSUE, THE PATIENT CLAIMED TO HAVE CONTINUED ADMINISTERING HER USUAL DOSE OF HUMALOG (SLIDING SCALE) DAILY. THE PATIENT STATED SHE FELT SHAKY 1-2 HOURS AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO HER SYMPTOM, THE PATIENT INDICATED SHE WAS TREATED WITH FOOD/DRINK BY A NON-HEALTH CARE PROFESSIONAL (HCP). PER THE CCA DOCUMENTATION, THE PATIENT FEELS SYMPTOMS ONLY WHEN SHE TAKES TOO MUCH INSULIN BECAUSE SHE IS GUESSING HOW MUCH BOLUS INSULIN TO TAKE BASED ON HER CARBOHYDRATE COUNTER. AT THE TIME THE ALLEGED ISSUE BEGAN, THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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. 3204039

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R