BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3121002 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12150
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 23, 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
    OR, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 ,THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH PING METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 AT 4:30 PM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 92 MG/DL, 161 MG/DL, 185 MG/DL AND 87 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES. THE PATIENT CLAIMED THAT TWO OF THESE READINGS WERE INACCURATELY HIGH COMPARED TO HER EXPECTED VALUE OF 120 MG/DL. THE PATIENT REPORTED SHE TOOK INSULIN BASED ON THESE READINGS VIA THE PUMP. AT 7:30 PM, THE PATIENT FELT HER BLOOD GLUCOSE LEVEL DROPPED, NO SPECIFIC SYMPTOMS WERE PROVIDED, AND RE-TESTED HER BLOOD GLUCOSE LEVEL TO BE 20 MG/DL. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT. NO INFORMATION WAS PROVIDED ABOUT THE TEST STRIPS, AS THEY WERE NO LONGER AVAILABLE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON ELEVATED METER READINGS, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221539 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R