BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2192059 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06840
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K082590. THE METER INVOLVED THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE RETURNED METER FAILED TESTING. THERE WAS CONTAMINATION FOUND ON THE METER'S PC BOARD. 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

    DEVICE EVALUATION: THE LAY USER/PATIENT'S METER 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 LOW/DEAD BATTERY. 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 HIS ONETOUCH PING METER IS USING BATTERIES TOO QUICKLY. ON (B)(6) 2011 THIS MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED PRODUCT ISSUE BEGAN APPROXIMATELY (B)(6) 2011 AT 11:00AM. THE PATIENT REPORTED THAT HE MANAGES HIS DIABETES WITH AN INSULIN PUMP. THE PATIENT FURTHER STATED THAT WHEN THE ISSUE BEGAN HE MADE NO CHANGES TO HIS DIABETES ROUTINE AND CONTINUED TO TEST WITH THE METER AFTER CHANGING THE BATTERIES. THE PATIENT REPORTED THAT ON (B)(6) 2011 WHILE CHANGING THE BATTERIES, HE BECAME "DIZZY" DUE TO THE PRODUCT ISSUE. THE PATIENT STATED THAT NO TREATMENT WAS RECEIVED DUE TO THE PRODUCT ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) THAT NO MISUSE WAS IDENTIFIED BUT THAT THE INCORRECT STRIPS WERE BEING USED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT'S SYMPTOMS DO NOT MEET THE CRITERIA FOR A SERIOUS INJURY AND THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION. HOWEVER, THIS MALFUNCTION IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3016564

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR