BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3022107 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06280
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 4, 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
    PA, 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 ((B)(4) 2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE 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 ERROR COULD NOT BE REPRODUCED. THE TEST STRIPS WERE FOUND TO HAVE A RESULTS OUTSIDE THE ACCEPTABLE CONTROL RANGE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- (B)(4) 2013, TEST STRIPS- (B)(4) 2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING INACCURATE READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL THREE TIMES AND ALLEGEDLY OBTAINED THE SAME READING OF "196 MG/DL" ON THE REPORTED METER. THE PATIENT TESTED IN THE MORNING, 7:00 PM AND 11:00 PM. THE PATIENT TOOK HER USUAL SET DOSES OF INSULIN. ON (B)(6) 3013 AT 1:30 AM THE PATIENT'S HUSBAND FOUND HER PASSED OUT. EMERGENCY SERVICES WERE CONTACTED. WHEN PARAMEDICS ARRIVED, THEY TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 30 MG/DL. THE PATIENT WAS UNABLE TO PROVIDE DETAILS ABOUT WHAT TREATMENT SHE RECEIVED. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING ELEVATED READINGS ON THE REPORTED METER AND TAKING INSULIN, AND RECEIVED EMERGENCY MEDICAL ATTENTION. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123246 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3286220

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R