BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 6438348 · Received March 28, 2017

    Report

    Report Number
    3008382007-2017-14608
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    March 19, 2017
    Report Date
    March 20, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH PING METER READ INACCURATELY ERRATIC AND INACCURATE COMPARED TO A CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2017. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿203, 230, 218, 290 AND 305 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS WITHIN LIFESCAN¿S CRITERIA FOR PRECISION. THE PATIENT ALSO REPORTED OBTAINING AN INACCURATE RESULT WITH THE SUBJECT METER COMPARED TO A RESULT OBTAINED ON A CGM DEVICE. THE EXACT RESULTS WERE NOT PROVIDED. LIFESCAN DOES NOT CONSIDER THIS TO BE A VALID COMPARISON. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH INSULIN (VIA INSULIN PUMP) AND DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURACY ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOM OF ¿THIRST¿ 4 DAYS AFTER THE ALLEGED ISSUE STARTED. IN RESPONSE TO THE SYMPTOM, THE PATIENT CLAIMED SHE WAS TREATED WITH 5 UNITS OF HUMALOG INSULIN BY A NON-HCP ON (B)(6) 2017. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING AND THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THE PRODUCTS INVOLVED IN THE COMPLAINT WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223226 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4132499

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R