BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5503371 · Received March 16, 2016

    Report

    Report Number
    2939301-2016-12423
    Event Type
    Injury
    Date Received
    March 16, 2016
    Report Date
    March 12, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETAIN TEST STRIPS HAVE BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ALTHOUGH PERFORMANCE TESTING WITH CONTROL SOLUTION DID NOT CONFIRM THE REPORTED ISSUE, THE RETAINED TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE. IN ADDITION, 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 RETAIN TEST STRIPS FAILED PERFORMANCE TESTING WITH CONTROL SOLUTION. 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 LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER DISPLAYED INACCURATELY HIGH RESULTS WHEN TESTING WITH CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ISSUE OCCURRED TWO WEEKS PRIOR TO CONTACTING LFS. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. THE PATIENT REPORTED DEVELOPING A SYMPTOM OF SWEATY PRIOR TO THE ISSUE AND THAT 2 WEEKS AGO AT 08:00AM SHE CONSUMED FOOD OR DRINK. DURING TROUBLESHOOTING THE CCA NOTED THAT THE PATIENT HAD USED THE CORRECT CONTROL SOLUTION AND FOLLOWED THE CORRECT TESTING PROCEDURE. THE METER WAS SET TO THE CORRECT UNIT OF MEASURE HOWEVER THE CONTROL SOLUTION HAD BEEN OPEN LONGER THAN RECOMMENDED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT SUFFERED SYMPTOMS THAT MEET LFS CRITERIA OF A SERIOUS HYPOGLYCEMIC EVENT AFTER THE ALLEGED METER ISSUE OCCURRED. IT CANNOT BE RULED OUT THAT THE METER DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159429 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3802643

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R