BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2143476 · Received June 29, 2011

    Report

    Report Number
    2939301-2011-05363
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE INITIAL REPORT INFORMATION WAS MISSING. SHOULD BE CHECKED MARKED AS LIFE THREATENING AND REQUIRED INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL INFORMATION: PATIENT OUTCOME ATTRIBUTED TO ADVERSE EVENT WAS OMITTED IN ERROR ON THE 3500A

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K082590. LFS HAS RECIVED THE PRODUCT BACK FROM THE PATIENT AND THE FOLLOWING INFORMATION WAS NOTED THAT THE CRACKED DISPLAY WAS BROKEN/ CRACKED. THE PATIENT'S ALLEGED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 1

    THE LAY REPORTER/ FATHER CONTACTED LFS ON (B)(6) 2011 ALLEGING A CRACKED DISPLAY ON HIS SON'S ONE TOUCH PING METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL REPORTED PLACED BY THE REPORTER: THE FATHER FIRST NOTICED THE CRACKED DISPLAY ON THE METER ON (B)(6) 2011 AT AROUND 12:30PM. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO OBTAIN A READING ON THE LFS METER. APPROXIMATELY 15 MINUTES LATER, THE PATIENT DEVELOPED SYMPTOMS OF "LOW BLOOD GLUCOSE" AND FAINTED. THE PATIENT CONTACTED AN HCP FOR ADVICE AND THE PATIENT SELF-TREATED WITH GLUCOSE TABLETS AND JUICE. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION. AT 5:46 PM THE SAME DAY, THE PATIENT TESTED ON ANOTHER DEVICE AND OBTAINED A 121 MG/DL THERE WAS NO MISUSE OF THE PRODUCT AND THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE CRACKED DISPLAY, THE PATIENT WAS UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY BASED ON LFS DEFINITION AND HAD TO SELF-TREAT WITH GLUCOSE TABLETS AND DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3115904

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening| R