BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3102212 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10754
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 24, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ ((B)(4) 2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS PASSED THE PERFORMANCE TESTING WITH BLOOD. 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/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRAMINI METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE OCCURRED THE MORNING OF (B)(6) 2013. THE REPORTER STATED THE PATIENT USES SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTER STATED ON THE MORNING OF THE ALLEGED ISSUE, THE PATIENT "PASSED OUT." THE REPORTER WAS UNSURE IF THE ALLEGED SYMPTOMS OCCURRED PRIOR TO OR AFTER THE ALLEGED ISSUE OCCURRED. THE REPORTER STATED THE PATIENT OBTAINED A READING OF "27MG/DL' ON THE LFS METER COMPARED TO "7MG/DL" ON AN UNKNOWN METER. IT IS NOT KNOWN HOW MUCH TIME PASSED IN BETWEEN THE READINGS. THE REPORTER STATED THE PATIENT RECEIVED "GLUCAGON, SHOT IN THE NECK" AS TREATMENT AND WAS TRANSPORTED TO THE ER AND ADMITTED UNTIL (B)(6) 2013. IT IS UNCLEAR IF THE PATIENT WAS TREATED FOR ANY OTHER DIAGNOSES IN ADDITION TO AN ACUTE COMPLICATION OF DIABETES. 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, SEVERELY LOW BLOOD GLUCOSE READINGS WERE OBTAINED AND THE PATIENT REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203154 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3417487

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R