BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2251588 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09139
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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.THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRALINK METER WOULD NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE REPORTER FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE REPORTER STATED THE ALLEGED ISSUE BEGAN APPROXIMATELY 4 WEEKS AGO ALTHOUGH COULD NOT RECALL THE EXACT DATE/TIME. THE PATIENT MANAGES HER DIABETES USING INSULIN PUMP THERAPY (UNKNOWN TYPE). IT IS UNCLEAR WHAT ACTIONS THE PATIENT TOOK WHEN SHE WAS UNABLE TO CHECK HER BLOOD GLUCOSE WITH THE SUBJECT METER. THE REPORTER CLAIMED THAT 1 HOUR LATER, THE PATIENT DEVELOPED SYMPTOMS OF "A HEADACHE AND HAD KETONES." IT IS UNCLEAR HOW THE REPORTER CONFIRMED THE PRESENCE OF KETONES. THE REPORTER CLAIMED THAT PATIENT CONSUMED FOOD AND OR DRINK APPROXIMATELY 5 MINUTES LATER FOR UNKNOWN REASONS. THE REPORTER DENIED THAT THE PATIENT RECEIVED ANY MEDICAL TREATMENT DUE TO HER REPORTED SYMPTOMS. IT IS UNCLEAR IF THE PATIENT USED ANOTHER DEVICE TO CHECK HER BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER'S BATTERIES DID NOT NEED TO BE REPLACED BASED ON THE METER'S SPECIFICATIONS. THE CORRECT TESTS STRIPS WERE BEING USED. THE ISSUE REMAINED UNRESOLVED AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3055432

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening