BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2112178 · Received June 3, 2011

    Report

    Report Number
    2939301-2011-04546
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Report Date
    May 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 ((B)(4) 2011) - 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 PCB CONTAMINATION. 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 CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER DISPLAYED AN "ER 1" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR WHAT ACTION SHE TOOK AT THE TIME OF THE ALLEGED ISSUE. IMMEDIATELY PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SHAKY. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED IT WAS NOT THE FIRST TIME THE SUBJECT METER WAS BEING USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOM STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED "ER 1" MESSAGE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3061930

    Patients

    Seq Age Sex Outcome Treatment
    1