BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3233332 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20254
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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

    FOLLOW-UP # 1 ¿ (08/06/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/26/2013 AND 7/31/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (08/22/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/6/2013 AND 8/16/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER 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 (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HER FEELINGS OR NORMAL RESULTS AND 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 IN THE AFTERNOON. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT ALLEGED OBTAINING READINGS OF ¿200, MAYBE 291 MG/DL¿ AND ¿291 MG/DL¿ COMPARED TO ¿40¿S MG/DL¿ ON A FREESTYLE METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4) WHEN OBTAINED WITHIN 30 MINUTES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 10-15 MINUTES AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED SYMPTOMS OF FEELING ¿SHAKY AND FLASHING LIGHTS.¿ THE PATIENT DENIED HAVING ANY TREATMENT IN RESPONSE TO THE ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE TEST STRIPS WERE IN GOOD CONDITION. HOWEVER 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. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335920 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3366658

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening