BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING METER

    MDR report key: 1619672 · Received February 25, 2010

    Report

    Report Number
    2939301-2010-01089
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    February 21, 2010
    Report Date
    February 22, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/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.

    Description of Event or Problem · 1

    ON FEB 22, 2010, THE LAY PT'S MOTHER CONTACTED LIFESCAN (LFS) (B) (4) ALLEGING THAT THE PT'S ONE TOUCH PING METER DISPLAYED A BLACK SCREEN WHEN A TEST STRIP WAS INSERTED INTO THE TEST STRIP PORT. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS TO LFS CANADA AND RECEIVED ANSWERS INCLUDED BELOW. THE MOTHER PROVIDED THE FOLLOWING INFO: THE PT TOOK INSULIN BASED ON A READING THAT APPEARED ON THE SCREEN. THE MOTHER TOLD THE CSR SHE BELIEVED THE READING UPON WHICH THE PT BASED HER INSULIN DOSAGE WAS > THAN THE LAST CURRENT METER READING OF 6.2 MMOL/L TAKEN ON (B) (6) 2010 AT 12:38 AM; HOWEVER, SHE DID NOT KNOW THE ACTUAL READING USED TO CALCULATE THE PT'S INSULIN DOSAGE. THE CSR WAS UNABLE TO WALK THE MOTHER THROUGH SCROLLING THROUGH THE METER MEMORY BECAUSE, THE METER TURNED OFF WHEN ANY METER BUTTON WAS PRESSED. ACCORDING TO THE MOTHER, THE PT FELT WEAK, DIZZY, SHAKY, AND TIRED WITHIN 40 MINUTES OF TAKING THE ADDITIONAL INSULIN. THE PT WAS TESTED WITH A BACK UP METER; THE RESULT WAS 2.2 MMOL/L AND SHE TOOK FOOD AND/OR BEVERAGE AS SELF-TREATMENT. THE CSR CONFIRMED THAT THE PT WAS USING ONE TOUCH ULTRA TEST STRIPS, LOT NO. 2941167. THE PT'S PRODUCT WAS REPLACED. THIS COMPLAINT IS REPORTED BECAUSE, THE PT'S MOTHER ALLEGES THE PT TOOK INSULIN BASED ON A PREVIOUS METER RESULT THAT DISPLAYED ON THE METER SCREEN. AT THAT TIME, THE METER DISPLAY WAS DESCRIBED AND GOING BLACK WHEN A OT ULTRA TEST STRIP WAS INSERTED INTO THE METER. THE MOTHER CLAIMS THE PT BECAME SHAKY, DIZZY, WEAK AND TIRED WITHIN 40 MINUTES OF TAKING THE ADDITIONAL INSULIN AND WAS SELF TREATED WITH FOOD AND/OR BEVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2941167

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening| R