BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2830180 · Received November 13, 2012

    Report

    Report Number
    2939301-2012-13052
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 26, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012, WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2012 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE 8X DAILY AND MANAGES HER DIABETES WITH HUMALOG INSULIN THROUGH PUMP THERAPY. THE ALLEGED ISSUE BEGAN ABOUT 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT'S GRANDDAUGHTER REPORTEDLY FOUND THE PATIENT INCOHERENT ON THE KITCHEN FLOOR. THE PATIENT WAS NOT ABLE TO CONFIRM IF SHE HAD "PASSED OUT". EMERGENCY MEDICAL SERVICES (EMS) WAS IMMEDIATELY CONTACTED. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT "100 POINTS DIFFERENT" WITH THE SUBJECT METER COMPARED TO THE EMS METER; HOWEVER, RESULTS WERE NOT SPECIFIED. THE PATIENT WAS ADMINISTERED A GLUCAGON INJECTION AS TREATMENT. THE PATIENT DID NOT RECALL RESULTS OBTAINED WITH THE SUBJECT METER PRIOR TO HER REPORTED SYMPTOMS; HOWEVER, DENIED MAKING CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT DID NOT HAVE HER TESTING SUPPLIES TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT WAS TREATED BY A HEALTH CARE PROFESSIONAL (HCP), THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOMS OCCURRED BEFORE THE ALLEGED ISSUE FIRST BEGAN. THE PATIENT DOES NOT RECALL WHAT HER READINGS WERE PRIOR TO THE ONSET OF HER REPORTED SYMPTOMS; HOWEVER, DENIED MAKING CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY REMAINED UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR