BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1860889 · Received October 7, 2010

    Report

    Report Number
    2939301-2010-08930
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Report Date
    October 4, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE CRACKED/BROKEN DISPLAY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER 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

    THE LAY USER/PATIENT'S REPORTER CONTACTED LIFESCAN ALLEGING THAT THE METER DISPLAYS BLACK MARKS. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    THE LAY USER /PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2010 ALLEGING THAT HER LANCET HOLDER WAS DAMAGED ON HER ONE TOUCH MINI LANING DEVICE. THE PATIENT HAS HAD THE PRODUCT FOR 2 YEARS, PRIOR TO THE ALLEGED REPORTED ISSUE. THE PATIENT DOES NOT RECALL WHEN SHE FIRST NOTICED THAT THE LANCET HOLDER WAS DAMAGED. THE PATIENT MENTIONED THAT SINCE IT WAS DAMAGED, SHE HAD STOPPED ATTEMPTING TO TEST HER BLOOD GLUCOSE. SOMETIME LAST WEEK AT AN UNSPECIFIED DATE AND TIME, SHE DEVELOPED SYMPTOMS OF FEELING THIRSTY AND FREQUENT URINATION, WHICH SHE ASSOCIATES WITH HIGH BLOOD GLUCOSE LEVEL. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR SELF-TREAT DUE TO THE ALLEGED ISSUE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER NOT BEING ABLE TO TEST DUE TO A DAMAGED LANCET HOLDER ON HER ONE TOUCH MINI LANCING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3046348

    Patients

    Seq Age Sex Outcome Treatment
    1