BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3020497 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06258
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED 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) ALLEGING HIS ONETOUCH ULTRA METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED, THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT AN UNKNOWN TIME. THE PATIENT REPORTED OBTAINING READINGS OF "180MG/DL" COMPARED TO "113MG/DL" ON AN ONETOUCH ULTRAMINI METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL OBTAINED WITHIN 30 MINUTES OF ONE ANOTHER. THE PATIENT REPORTED IN RESPONSE TO THE ALLEGED READING HE ADMINISTERED HIS USUAL MEDICATION ON (B)(6) 2013, 60 UNITS OF LANTUS INSULIN. THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME HE DEVELOPED SYMPTOMS OF "SWEATING, CHILLS AND NAUSEA." THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION IN RESPONSE TO HIS SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING PROCESS AND AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLE. 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 AND THE PRODUCTS WERE REQUESTED FOR RETURN FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, SHE SELF ADMINISTERED HER USUAL DOSE OF MEDICATION AND DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124069 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3394332

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening