BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1923471 · Received December 13, 2010

    Report

    Report Number
    2939301-2010-10691
    Event Type
    Injury
    Date Received
    December 13, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/15/2010. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE SPC PIN 4 LIFTED HIGH. A SECONDARY ISSUE WAS ALSO NOTED AS SPC DIRTY IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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. 510(K) # IS K073231.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HIGH MEASUREMENT OF IMPEDANCE ON THE RIGHT VENTRICULAR LEAD AND THAT OTHER MEASUREMENTS HAD BEEN IN RANGE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WOULD NOT POWER ON WITH THE TEST STRIP. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2010, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON WHEN THE TEST STRIP WAS INSERTED; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THIS METER ISSUE. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF NAUSEA, DIZZINESS, FREQUENT URINATION, THIRST AND FATIGUE. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HER DIABETES BY TAKING INSULIN USING A PUMP. TROUBLESHOOTING REVEALED THE METER WOULD POWER ON WITH THE POWER BUTTON BUT NOT UPON TEST STRIP INSERTION, THE TEST STRIPS WERE CORRECT AND THERE HAD BEEN NO MISUSE OF THE PRODUCT. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE METER POWER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2946374

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening