BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2221123 · Received August 24, 2011

    Report

    Report Number
    2939301-2011-07577
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    August 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE 510(K)# IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS EXPERIENCING AN ISSUE WITH "OTHER MESSAGE". THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT SHE MANAGES HER DIABETES WITH THE INSULIN PUMP. THE PATIENT STATED THAT ON (B)(6) 2011 BETWEEN 7:00 AND 8:00PM, SHE ALLEGEDLY OBTAINED A DISPLAY OF "UNABLE TO COMMUNICATE, VERIFY SETTINGS" WHEN TRYING TO TEST WITH THE SUBJECT METER. SHORTLY AFTER, THE PATIENT DECREASED HER HUMALOG INTAKE BY AN UNKNOWN NUMBER OF UNITS IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OR TO RECEIVING ANY MEDICAL TREATMENT. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS UNWILLING/UNABLE TO RESOLVE THE ALLEGED PRODUCT ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DID NOT SUFFER FROM ANY SERIOUS INJURIES AND DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1