BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING ENHANCED METER

    MDR report key: 3242121 · Received July 23, 2013

    Report

    Report Number
    3008382007-2013-20810
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 (09/10/2013)-PRODUCT EVALUATION: THE ANALYSIS OF THE TEST STRIPS WAS COMPLETED ON 09/03/2013 BY LIFESCAN PRODUCT ANALYSIS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE PRODUCT MET ALL SPECIFICATIONS FOR TESTING AND NO ISSUES WERE OBSERVED DURING INVESTIGATION. 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

    FOLLOW-UP # 1 ¿ (08/21/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/9/2013 AND 8/13/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING A ONETOUCH PING ENHANCED METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING (B)(6) 2013. THE PATIENT ALLEGED OBTAINING READINGS OF ¿18MMOL/L¿ ON THE LFS METER COMPARED TO ¿10 OR 12 MMOL/L¿ ON A FREESTYLE METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL WHEN OBTAINED WITHIN 30 MINUTES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ON AN UNKNOWN DATE AT AN UNKNOWN TIME SHE DEVELOPED SYMPTOMS OF FEELING ¿SHAKY¿ WHICH SHE ASSOCIATED WITH LOW BLOOD GLUCOSE. THE PATIENT REPORTED IN RESPONSE TO THE SYMPTOMS SHE HAD MARSHMALLOWS TO INCREASE HER BLOOD GLUCOSE. THE PATIENT REPORTED NO ADDITIONAL METERS WERE USED TO MEASURE HER BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE TEST STRIPS WERE IN GOOD CONDITION. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING STEPS AND AN APPROVED SAMPLE SITE. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342770 OT PING ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3383950

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R