BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1984139 · Received February 10, 2011

    Report

    Report Number
    2939301-2011-01280
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A CRACKED/DAMAGED DISPLAY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER HAS BLACK MARKS IN THE DISPLAY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS SEVEN TIMES A DAY AND MANAGES HER DIABETES WITH INSULIN (ADMINISTERED VIA INSULIN PUMP). THE PATIENT CONFIRMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 7PM. AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CORRECTED AND CLARIFIED SHE IMMEDIATELY TESTED HER BLOOD GLUCOSE WITH HER SECONDARY METER. THE PATIENT CORRECTED AND CLARIFIED SHE DID NOT DEVELOP ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT ALSO CORRECTED AND CLARIFIED SHE DID NOT RECEIVE ANY MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE BEGAN. DURING TROUBLESHOOTING, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) NOTED THERE WAS NO MISUSE OF THE LFS PRODUCT. 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 SUFFER FROM ANY SERIOUS INJURIES AND 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR