BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2862432 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07502
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. TEST STRIP LOT #: NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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) 2012 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) 2012 AT 5:25 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 342 MG/DL ON THE REPORTED METER. AT AN UNSPECIFIED TIME, THE PATIENT OBTAINED THE READING OF "LESS THAN 50 MG/DL" ON THE DEXCOM CONTINUOUS GLUCOSE MONITORING SYSTEM. BASED ON HER IPT PROTOCOL, THE PATIENT CORRECTED HER ELEVATED BLOOD GLUCOSE LEVEL WITH A 3.75 UNIT BOLUS DOSE OF INSULIN VIA THE PUMP. AT 7:00 AM THE PATIENT WAS FOUND UNCONSCIOUS, AND EMERGENCY MEDICAL SERVICES WERE CONTACTED. AT 8:00 AM PARAMEDICS ARRIVED AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 30 MG/DL. THE PATIENT WAS TREATED INTRAVENOUSLY WITH GLUCOSE. TROUBLESHOOTING REVEALED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING AN INSULIN BOLUS BASED ON AN ELEVATED METER READING, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH GLUCOSE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R