BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3021673 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06275
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED THE REPORTED METER TO LIFESCAN FOR EVALUATION. ON (B)(4) 2013, PRODUCT ANALYSIS TESTED THE METER WITH FAILING RESULTS. THE METER WOULD NOT POWER ON, IT HAD A HIGH SLEEP CURRENT, AND THE PCB BOARD WAS CONTAMINATED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION AT IC114. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH PING METER WAS GIVING THE ERROR 1 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, AT 1:00 PM THE PATIENT OBTAINED THE ERROR 1 ERROR MESSAGE ON THE REPORTED METER; HE DID NOT OBTAIN A BLOOD GLUCOSE READING. AT THAT SAME TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOM OF BEING INCOHERENT. EMERGENCY SERVICES WERE CONTACTED. AT 2:00 PM PARAMEDICS ARRIVED AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL, HOWEVER, THAT RESULT WAS NOT PROVIDED. THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION. THE PATIENT MANAGES HIS DIABETES WITH INSULIN PUMP THERAPY. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT RETURNED THE REPORTED METER TO LIFESCAN FOR EVALUATION. ON (B)(6) 2013, PRODUCT ANALYSIS TESTED THE METER WITH FAILING RESULTS. THE METER WOULD NOT POWER ON, IT HAD A HIGH SLEEP CURRENT, AND THE PCB BOARD WAS CONTAMINATED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA WHILE USING THE METER, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH GLUCAGON. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124460 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3407998

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R