BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3914965 · Received July 5, 2014

    Report

    Report Number
    2939301-2014-16533
    Event Type
    Injury
    Date Received
    July 5, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 27, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/29/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 7/16/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/18/2014 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) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (B)(6) ALLEGING THEIR ONETOUCH ULTRAMINI METER WAS DISPLAYING AN ERROR 5 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON(B)(6) 2014 AT APPROXIMATELY 11:04PM. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES BUT HE STATED HE DID NOT MAKE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE. THE PATIENT REPORTED THAT HE WENT TO SEE HIS DOCTOR THE FOLLOWING MORNING TO GET HIS BLOOD GLUCOSE CHECKED. THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE WAS CHECKED AT THE DOCTOR¿S OFFICE AT APPROXIMATELY 8AM ON (B)(6) 2014 AND A READING OF ¿316MG/DL¿ WAS OBTAINED (ACCUCHECK). THE PATIENT WAS TREATED BY HIS DOCTOR WITH 4 UNITS OF MONGLISAR ALSO AT 8AM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. THE ISSUE WAS RESOLVED WITH A RETEST DURING TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY WAS UNABLE TO TEST HIS BLOOD GLUCOSE AND REQUIRED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) FOR A HIGH BLOOD GLUCOSE EXCURSION AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392968 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3635629

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R