BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1844477 · Received September 25, 2010

    Report

    Report Number
    2939301-2010-08460
    Event Type
    Malfunction
    Date Received
    September 25, 2010
    Report Date
    September 22, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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; 510 (K) # IS K073231.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PINS HIGH. 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.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON WITH STRIP INSERTION. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    A PT REPORTED THAT SHE HAD PAIN AND TIGHTNESS, AS SHE EXPERIENCED A SLIGHT RETURN OF SYMPTOMS AT NIGHT. THE RETURNED SYMPTOMS HAD CONTINUED INTO THE FOLLOWING DAY. THE PT WAS NOTED TO HAVE BEEN IN THE SAME ROOM AS HER SON, WHO WAS RECEIVING AN MRI SCAN WITH CONTRAST ON (B)(6) 2010. FOR CLARIFICATION, THE PT DID NOT RECEIVE AN MRI, BUT WAS IN THE SAME ROOM FOR 40 MINUTES WHILE THE MRI WAS BEING CONDUCTED. THE PT WAS AT HOME AT THE TIME OF THE REPORT. THE PT THOUGHT THAT THE RETURN OF HER SYMPTOMS MAY HAVE BEEN TRIGGERED BY STRESS, AND WASN'T SURE IF MRI INTERFERENCE WAS A FACTOR. THE PT HAD A SPINAL HEADACHE THE WEEK PRIOR, AND HER PHYSICIAN BELIEVED SHE HAD A FLUID LEAK REGARDING HER CATHETER. IT WAS FURTHER REPORTED THAT THE PATIENT'S CATHETER HAD DISLODGED A YEAR OR MORE AGO, WHICH CAUSED A PREVIOUS LOSS OF THERAPEUTIC BENEFIT (REFER TO MANUFACTURER REPORT #3004209178200906992). THE PATIENT'S OUTCOME, IN ADDITION TO THE TYPE OF MEDICATION, CONCENTRATION AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3047538

    Patients

    Seq Age Sex Outcome Treatment
    1