BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1891470 · Received November 4, 2010

    Report

    Report Number
    2939301-2010-09690
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 15, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K082590. ON (B)(6) 2010: THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER DISPLAY WAS FADING. 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 TECHNICAL SERVICE REPRESENTATIVE (TSR). THE PATIENT DOES NOT RECALL THE DATE/TIME WHEN THE ALLEGED ISSUE BEGAN. IT IS NOT KNOWN HOW OFTEN THE PATIENT TESTS HER BLOOD GLUCOSE AND IT IS UNSPECIFIED IF THE PATIENT CONTINUED TO USE THE SUBJECT METER AFTER THE ALLEGED ISSUE BEGAN. ACCORDING TO THE TSR'S DOCUMENTATION, THE PATIENT STATED SHE MANAGES HER DIABETES WITH AN INSULIN PUMP; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER DISPLAY ISSUE. THE PATIENT INDICATED SHE OWNS A SECONDARY METER (TYPE UNKNOWN); HOWEVER, IT IS NOT KNOWN WHEN THE PATIENT BEGAN TESTING WITH HER SECONDARY METER, SPECIFIED BLOOD GLUCOSE RESULTS WERE NOT PROVIDED, AND IT IS NOT KNOWN IF THE PATIENT ADMINISTERED HER INSULIN BASED ON HER SECONDARY METER READINGS. ON UNSPECIFIED DATES/TIMES FOLLOWING THE REPORTED METER ISSUE, THE PATIENT CLAIMED SHE EXPERIENCED UNSPECIFIED SYMPTOMS OF EITHER HIGH OR LOW BLOOD GLUCOSE; PATIENT'S BLOOD GLUCOSE RESULTS PRIOR TO THE ONSET AND/OR DURING HER SYMPTOMS ARE UNKNOWN. IT IS NOT SPECIFIED HOW LONG THE PATIENT'S ALLEGED HIGH OR LOW BLOOD GLUCOSE SYMPTOMS PROGRESSED OR WHEN THE SYMPTOMS DETERIORATED; ACCORDING TO TSR'S DOCUMENTATION, THE PATIENT DENIED SHE RECEIVED TREATMENT AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE TSR NOTED THAT THE LFS PRODUCT WAS NOT MISUSED AND THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNCLEAR IF THE PATIENT CONTINUED TO USE THE SUBJECT METER AFTER THE ALLEGED ISSUE BEGAN AND IT IS UNKNOWN IF THE PATIENT ADMINISTERED HER INSULIN ACCORDING TO THE RESULTS WITH HER SECONDARY METER, BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE 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. 3027262

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening