BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3020481 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06257
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED 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. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER WAS NOT COMMUNICATING WITH HIS INSULIN PUMP. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE HAD BEEN RECURRING INTERMITTENTLY FOR THE LAST WEEK PRIOR TO CONTACTING LFS. THE PATIENT REPORTED USING INSULIN PUMP THERAPY TO MANAGE HIS DIABETES. THE PATIENT REPORTED AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS ASSOCIATED WITH HIGH BLOOD GLUCOSE INCLUDING "SPILLING KETONES AND NOT FEELING GOOD." THE PATIENT REPORTED ON (B)(6) 2013, HE WAS SEEN IN HIS DOCTOR'S OFFICE. THE PATIENT REPORTED AN UNKNOWN READING WAS OBTAINED WITH THE DOCTOR'S BLOOD GLUCOSE METER. THE PATIENT REPORTED ON (B)(6) 2013, HE HAD AN UNKNOWN INCREASED DOSE OF MEDICATION. DURING THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE CUSTOMER WAS ABLE TO HAVE AN ACTIONABLE RESULT (READING UNKNOWN). THE CCA NOTED THAT THE RESULT DOES FLASH AND THE "RF" FEATURE WAS TURNED ON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND THE PRODUCTS WERE REQUESTED FOR RETURN. THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO TREAT HIMSELF USING A MANUAL ENTRY METHOD WITH THE INSULIN PUMP, THEREFORE, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124414 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3397328

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R