BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2983129 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03943
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER WAS FOUND TO HAVE PCB CONTAMINATION. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER WOULD NOT POWER ON, WOULD NOT POWER OFF AND THE OK BUTTON WAS NON RESPONSIVE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT AN UNKNOWN TIME IN THE AFTERNOON. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH AN UNKNOWN TYPE AND DOSE OF INSULIN THROUGH PUMP THERAPY AND REPORTEDLY DECREASED HIS FOOD/DIET INTAKE BY SKIPPING LUNCHES AS OF (B)(6) 2013. THE PATIENT CLAIMED HE DEVELOPED 'HIGH BLOOD GLUCOSE SYMPTOMS' 1-2 DAYS LATER BUT DESPITE HIS SYMPTOMS HE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. IT IS UNCLEAR WHETHER THE PATIENT WAS UNABLE TO CHECK HIS BLOOD GLUCOSE DUE TO THE ISSUES AND THEREFORE DEVELOPED THE SYMPTOMS. IT WOULD HAVE ALSO BEEN HELPFUL TO UNDERSTAND WHAT SPECIFIC SYMPTOMS OF HIGH BLOOD GLUCOSE THE PATIENT WAS EXPERIENCING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE METER POWERED ON BY INSERTING A TEST STRIP BUT NOT WITH THE POWER BUTTON. THE OK BUTTON ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87435 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3373538

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening