BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 6165635 · Received December 12, 2016

    Report

    Report Number
    3008382007-2016-63658
    Event Type
    Injury
    Date Received
    December 12, 2016
    Report Date
    December 2, 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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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) 2016 THE REPORTER CONTACTED LIFESCAN ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER ALLEGED THAT THE PRODUCT ISSUE BEGAN IN (B)(6) 2016. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION, INCLUDING METFORMIN, HUMALOG AND LANTUS. THE REPORTER STATED THAT THE PATIENT CONTINUED TO TAKE THEIR USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER STATED THAT AT 3PM ON (B)(6) 2016 THE LAY USER/PATIENT DEVELOPED SYMPTOMS OF ¿DISORIENTATION, STUTTERING, SHAKING AND COULD NOT SAY A FULL SENTENCE¿. THE REPORTER STATED THAT THEY CALLED 911 AND EMERGENCY MEDICAL SERVICES (EMS) CAME TO THE PATIENT¿S HOME. THE REPORTER STATED THAT THE PATIENT RECEIVED HCP TREATMENT BUT THEY WERE UNABLE TO PROVIDE FURTHER DETAILS. THE REPORTER STATED THAT THE EMS OBTAINED A BLOOD GLUCOSE READING OF 42MG/DL. THE REPORTER ALLEGED MULTIPLE INACCURACIES ON THE SUBJECT METER AFTER THE PATIENT DEVELOPED THE REPORTED SYMPTOMS. THE REPORTER STATED THAT THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 180MG/DL ON THE SUBJECT METER AND 130MG/DL ON A ONETOUCH ULTRA2 METER, OBTAINED WITHIN 30 MINUTES OF EACH OTHER. THE REPORTER ALSO STATED THAT THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF 227, 180, 295, 230, 221 AND 249MG/DL ON THE SUBJECT METER AND ALLEGED THAT THEY WERE INACCURATELY HIGH COMPARED TO THE PATIENT¿S NORMAL READINGS AND/OR FEELINGS. THE REPORTER ALSO STATED THAT THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 69MG/DL ON THE SUBJECT METER AND 42MG/DL ON AN EMS METER, OBTAINED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THESE READINGS EXCEED LIFESCAN¿S CRITERIA FOR ACCURACY. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE SUBJECT METER HAD RECENTLY PASSED A CONTROL SOLUTION TEST; HOWEVER, THE REPORTER DIDNOT HAVE ANY TEST STRIPS LEFT TO REPEAT THIS TEST. THE CCA ALSO NOTED THAT THE PATIENT WAS FACING AN ISSUE WITH THE DATE/TIME SETTINGS AND THE METER DID NOT REVERT TO SET UP MODE WHEN THE BATTERY WAS CHANGED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LIFESCAN¿S CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817201 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R