BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1900377 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09920
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    November 3, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER HAS BLACK MARKS IN THE DISPLAY. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN BETWEEN (B)(6) 2010 (AFTER 3PM). THE PATIENT STATED SHE MANAGES HER DIABETES WITH INSULIN (GIVEN VIA INSULIN PUMP). THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER DISPLAY ISSUE. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT CLAIMED SHE DEVELOPED STOMACH PAINS (DATE/TIME NOT SPECIFIED). THE PATIENT, HOWEVER, DENIED RECEIVING MEDICAL INTERVENTION OR TREATMENT AFTER THE ALLEGED ISSUE BEGAN. DURING TROUBLESHOOTING, THE PATIENT INFORMED THE CSR SHE HAS A BACKUP METER TO USE. THE CSR NOTED THERE WAS NO TRAUMA TO THE SUBJECT METER AND THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3048299

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR