BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1828347 · Received September 8, 2010

    Report

    Report Number
    2939301-2010-07675
    Event Type
    Injury
    Date Received
    September 8, 2010
    Report Date
    August 23, 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. 510(K)# IS K080639.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A PRODUCT USABILITY ISSUE WITH THE ONETOUCH PING METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ONE YEAR AGO (DATE/TIME NOT SPECIFIED). FROM THE TIME HE OBTAINED THE SUBJECT METER (ONE YEAR AGO), THE PATIENT CLAIMED HE HAS NOT BEEN ABLE TO READ THE DISPLAY DUE TO THE COLORS OF THE SCREEN. THE PATIENT MANAGES HIS DIABETES WITH AN INSULIN PUMP; HOWEVER, IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK REGARDING HIS DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY DIABETES SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE. ACCORDING TO THE TSR'S DOCUMENTATION, BETWEEN A YEAR TO A YEAR AND A HALF AGO (DATE/TIME UNKNOWN), THE PATIENT CLAIMED HE TESTED WITH THE ER/HOSPITAL'S METER; HOWEVER, THE RESULT IS NOT KNOWN. THE PATIENT ALSO CLAIMED THAT DURING AN EMERGENCY ROOM VISIT (DATE/TIME UNKNOWN), HE RECEIVED A GLUCAGON INJECTION FROM A HEALTH CARE PROFESSIONAL. IT IS UNKNOWN IF THE PATIENT TESTED BETWEEN THE TIME OF THE REPORTED ISSUE AND THE TIME HE SOUGHT MEDICAL ATTENTION. ACCORDING TO THE TSR'S DOCUMENTATION, REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY RECEIVED A GLUCAGON SHOT FROM A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2932833

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening