BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 5503366 · Received March 16, 2016

    Report

    Report Number
    2939301-2016-12418
    Event Type
    Injury
    Date Received
    March 16, 2016
    Report Date
    March 10, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS AND THE INVESTIGATION CONCLUDED THAT INCORRECT TEST SPECIFICATIONS HAD BEEN USED DURING TESTING, WHICH HAVE BEEN ADDRESSED BY LIFESCAN'S QUALITY MANAGEMENT SYSTEM. THE METER HAS BEEN RE-EVALUATED FOLLOWING REVISED PROCEDURES USING THE CORRECT TEST SPECIFICATIONS, AND NO FAILURE RELATING TO INACCURACY WAS FOUND. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. ON SEPTEMBER 21, 2020, LFS RECEIVED NOTIFICATION FROM THE FDA THAT THIS SUPPLEMENTAL WAS ON-HOLD AND HAD NOT BEEN SUCCESSFULLY RECEIVED BY THE AGENCY. LFS HAS BEEN ENGAGED WITH THE FDA SINCE SEPTEMBER 21, 2020, TO AGREE UPON REMEDIATION OF THE ON-HOLD ISSUE. ON MARCH 11, 2020, THE WORLD HEALTH ORGANIZATION (WHO) DECLARED THE COVID-19 OUTBREAK AS A GLOBAL PANDEMIC. IN LINE WITH FINAL GUIDANCE PUBLISHED BY THE FDA IN MAY, 2020, ENTITLED 'POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING AN INFLUENZA PANDEMIC'; LFS HAS AGREED LATE REPORTING OF ALL ON-HOLD SUPPLEMENTALS. THIS SUBMISSION IS INCLUDED AS PART OF THAT AGREEMENT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1: THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. DUE TO THE TEST STRIPS NOT BEING RETURNED, PRODUCT ANALYSIS PERFORMED A RETAIN TEST. THE RETAIN TEST STRIP PASSED TESTING WITH NO FAULTS FOUND. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY ISSUE OCCURRED ON AN UNSPECIFIED DATE DURING "MID-(B)(6) 2015". AT THIS TIME THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "283, 253, 262, 316 AND 550MG/DL" WITH THE SUBJECT METER WITHIN 20 MINUTES OF ONE ANOTHER. THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES BY SELF-ADJUSTING THEIR INSULIN DOSAGE AND DENIED MAKING ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED PRODUCT ISSUE. LESS THAN HALF AN HOUR AFTER THE ALLEGED PRODUCT ISSUE OCCURRED, THE PATIENT DEVELOPED THE SYMPTOMS OF "DIZZY AND SHAKING". IN RESPONSE TO THESE SYMPTOMS THE PATIENT WAS GIVEN FOOD AND/OR DRINK BY MEANS OF TREATMENT FROM THEIR HOME HEALTH/VISITING NURSE. NO FURTHER MEDICAL TREATMENT WAS REQUIRED. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND AN APPROVED SAMPLE SITE WAS BEING USED. THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LFS'S CRITERIA FOR PRECISION. THE PATIENT'S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS THAT THEY OBTAINED INACCURATELY ERRATIC READINGS ON THE SUBJECT METER WHICH LED TO THEM SUFFERING SYMPTOMS WHICH ARE SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161230 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3891519

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R