BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2143164 · Received June 28, 2011

    Report

    Report Number
    2939301-2011-05332
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011) - DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6) 2011 THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. ON (B)(6) 2011 THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER READ INACCURATELY ERRATIC WHEN COMPARING RESULTS TAKEN ONE AFTER ANOTHER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) (YEAR NOT SPECIFIED). THE REPORTER STATED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "238 AND 69 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES OR WHAT ACTION HE TOOK AT THE TIME OF THE ALLEGED ISSUE. IMMEDIATELY PRIOR TO THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT WAS EXPERIENCING "MOOD CHANGES." THE REPORTER DENIED THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT SYMPTOMS DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3115218

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR