BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 5652640 · Received May 13, 2016

    Report

    Report Number
    2939301-2016-23519
    Event Type
    Injury
    Date Received
    May 13, 2016
    Report Date
    May 3, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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

    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 MAY 3, 2016 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY WHEN TESTING WITH CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO REMEMBER EXACTLY WHEN THE ALLEGED INACCURACY ISSUE BEGAN. THE PATIENT REPORTED OBTAINING A CONTROL SOLUTION RESULT OF 107MG/DL WHICH FALLS OUTSIDE OF THE SPECIFIED CONTROL RANGE OF ¿113 -151 MG/DL¿ FOR TEST STRIP LOT # 3898694. THE PATIENT MANAGES HER DIABETES USING INSULIN WITH NO ADJUSTMENTS AND REPORTEDLY INCREASED HER FOOD AND/OR DRINK CONSUMPTION ON (B)(6) 2016 IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿SHAKY, SWEATY AND DIZZY¿ AN UNSPECIFIED AMOUNT OF TIME AFTER THE ALLEGED ISSUE OCCURRED AND DENIED RECEIVING ANY FURTHER FORM OF MEDICAL INTERVENTION IN RESPONSE TO THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE CORRECT CONTROL SOLUTION WAS BEING USED, THE TEST STRIPS AND CONTROL SOLUTION WERE STORED CORRECTLY AND WITHIN EXPIRY. THE CSR WAS UNABLE TO WALK THE PATIENT THROUGH A CONTROL SOLUTION TEST. THE ISSUE REMAINED UNRESOLVED, AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308068 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3898694

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening