BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 6105770 · Received November 16, 2016

    Report

    Report Number
    3008382007-2016-59434
    Event Type
    Injury
    Date Received
    November 16, 2016
    Report Date
    October 29, 2016
    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
    OH, US
    Reporter Occupation
    PATIENT

    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

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS 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 OCTOBER 29, 2016 THE LAY USER/PATIENT MOTHER (REPORTER) CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER DAUGHTER'S ONETOUCH PING METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING, SINCE THE REPORTER WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE REPORTER WAS UNSURE WHEN THE ALLEGED METER ISSUE BEGAN; THE PATIENT WAS ADMITTED TO HOSPITAL APPROXIMATELY 2 DAYS PRIOR TO CONTACTING LFS DUE TO THE ALLEGED ISSUE. THE PATIENT IS ON INSULIN PUMP THERAPY. THE REPORTER CLAIMED THAT THE PATIENTS METER HAS BEEN READING INACCURATELY HIGH. IN RESPONSE TO THE ALLEGED METER ISSUE THE PATIENT DECREASED HER FOOD/DRINK INTAKE. IN THE FEW DAYS BEFORE ADMITTANCE THE PATIENT DEVELOPED THE SYMPTOM OF "LETHARGY". NO BLOOD GLUCOSE READINGS WERE PROVIDED FROM THIS PERIOD. UPON ADMISSION TO HOSPITAL THE PATIENT WAS TREATED WITH A GLUCOSE DRIP AND MONITORED BY HEALTH CARE PROFESSIONALS. ON THE MORNING OF (B)(6) 2016 THE REPORTER BEGAN COMPARING READINGS FROM THE HOSPITAL METER (ACCUCHEK INFORM 2) TO THE PATIENTS METER. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF 364 MG/DL WITH THE SUBJECT METER AND 277 MG/DL ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCANS CRITERIA FOR ACCURACY. DURING TROUBLESHOOTING THE CSR CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THAT THE TEST STRIPS WERE STORED PROPERLY WITH AN INTACT VIAL AND THAT THEY HAD NOT EXPIRED NOR EXCEEDED THEIR DISCARD DATE. THE PATIENTS TESTING PROCESS WAS CONFIRMED AS CORRECT AND SAMPLES WERE TAKEN FROM THE CORRECT SAMPLE SITE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. PRODUCTS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR 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
    757323 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4053960

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| L| R