BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2250083 · Received September 15, 2011

    Report

    Report Number
    2939301-2011-09056
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    September 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/18/2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS DISPLAYING THE MESSAGE "PC." THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). IT IS NOT KNOWN WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT'S DIABETES MANAGEMENT IS NOT SPECIFIED AND IT IS UNKNOWN WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. IT IS NOT KNOWN IF THE PATIENT DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE. IT IS ALSO NOT KNOWN IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTION/TREATMENT AFTER THE REPORTED METER ISSUE BEGAN. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE ALL HER TESTING SUPPLIES AVAILABLE. THE ALLEGED ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED. THERE IS NO EVIDENCE, HOWEVER, THAT THE PATIENT SUFFERED A SERIOUS INJURY BECAUSE OF THE ALLEGED ISSUE. THERE IS ALSO NO EVIDENCE THE PATIENT RECEIVED ANY FORM OF MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE BEGAN.

    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 53 YR