BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2003396 · Received March 1, 2011

    Report

    Report Number
    2939301-2011-01668
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1(03/03/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A 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

    ON (B)(6) 2011, THE LAY USER/PATIENT'S FATHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER WAS READING INACCURATELY LOW COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT'S FATHER FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT WHEN THE ALLEGED INACCURACY BEGAN. THE PATIENT'S FATHER REPORTED THAT ON (B)(6) 2011 AT AN UNSPECIFIED TIME THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "80S AND 84 MG/DL" WITH THE SUBJECT METER AND "HIGH"; WHICH HE INDICATED AS A RESULT OF OVER "500 MG/DL" ON ANOTHER METER(FREESTYLE BRAND METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT'S FATHER INDICATED THAT THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. AT AN UNKNOWN DATE/TIME, THE FATHER CLAIMED THE PATIENT BEGAN TO VOMIT AND CLAIMED THAT SHE TESTED POSITIVE FOR KETONES; HOWEVER THE FATHER WAS NOT ABLE TO SPECIFY WHETHER THE SYMPTOMS OCCURRED BEFORE OR AFTER THE ALLEGED ISSUE BEGAN. AT AROUND 9:00AM ON (B)(6) 2011, THE FATHER INDICATED BASED ON THE ALLEGED READING ON THE FREESTYLE METER AND HER SYMPTOMS, THE PATIENT WAS ADMINISTERED AN INCREASED DOSE OF NOVOLOG INSULIN (DOSE UNKNOWN). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT USED AN APPROVED SAMPLE SITE TO OBTAIN THE LFS RESULT(S), PATIENT'S TESTING PROCEDURE WAS CORRECT, AND THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY; HOWEVER THE FATHER DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS OF HYPERGLYCEMIA POSSIBLY AFTER OBTAINING INACCURATE LOW RESULTS ON THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3036899

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening| R