BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1845238 · Received September 27, 2010

    Report

    Report Number
    2939301-2010-08485
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.510K # K082590.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6), 2010 ALLEGING THAT THE ONETOUCH PING METER HAS BLACK MARKS ON THE DISPLAY. THE PATIENT'S DIABETES IS MANAGED WITH AN INSULIN PUMP. THE PRODUCT ISSUE BEGAN ON (B)(6), 2010 AT 2 PM. IT IS NOT KNOWN WHAT BLOOD GLUCOSE READING SHE OBTAINED OR IF THE BLOOD GLUCOSE READING ON THE SUBJECT METER. THE PATIENT REPORTEDLY HAD SYMPTOM OF FREQUENT URINATION; HOWEVER, THE PATIENT DOES NOT RECALL WHEN THE SYMPTOMS STARTED. AT 5 PM, A BLOOD GLUCOSE READING OF "235 MG/DL" WAS OBTAINED ON ANOTHER METER. THE PATIENT REPORTEDLY ADMINISTERED SELF TREATMENT WITH INSULIN PER THE REPORTED METER READING AT THE TIME OF CONCERN. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE BLACK MARKS ISSUE ON THE DISPLAY WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOM THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AFTER THE DISPLAY ISSUE BEGAN.

    Devices

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

    Patients

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