BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2221033 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07944
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    July 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K073231. ON (B)(4) 2011, LFS RECEIVED THE METER INVOLVED WITH THIS COMPLAINT AND DEVICE EVALUATION WAS COMPLETED WITH ON (B)(4) 2011. EVALUATION DETERMINED THAT THE RETURNED METER FAILED TESTING BECAUSE TESTING REVEALED CONTAMINATION ON THE PC BOARD. THIS COMPLAINT IS BEING REPORTED DUE TO THE FAILED DEVICE EVALUATION TESTING. THE PATIENT RETURNED A VIAL OF TEST STRIPS, (LOT # 2988164); HOWEVER, THIS TEST STRIP LOT WAS NOT INVOLVED WITH THE ALLEGED COMPLAINT. TESTING WAS STILL PERFORMED ON THE RETURNED TEST STRIPS AND THEY PASSED TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT AN "ER2" ISSUE WHEN ATTEMPTING TO DO HER GLUCOSE TEST USING WITH THE ONETOUCH ULTRALINK METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN AT 10:30AM ON (B)(6) 2011. SHE INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN (PUMP THERAPY) AND HAD TAKEN 3.7 UNITS OF NOVOLOG EARLIER IN THE MORNING AT 6AM. IT IS UNKNOWN IF SHE MADE ANY CHANGES TO HER USUAL TREATMENT DUE TO THE ALLEGED ISSUE. PRIOR TO ALLEGED ISSUE, AT 6 AM, SHE HAD INCREASED HER INSULIN DOSE (3.7U OF NOVOLOG). THE PATIENT CLAIMED THAT BEFORE THE ALLEGED ISSUE BEGAN, AT 10:30 AM, SHE FELT WEAK, SHAKY, AND SWEATY AND HAD BLURRED VISION. AT 10:30 AM, SHE REPORTEDLY SELF TREATED WITH FOOD AND DRINK DUE TO HER SYMPTOMS. NO OTHER DEVICE WAS AVAILABLE AT THE TIME OF CONCERN. DURING THE INITIAL CALL WITH CCA, THE PATIENT DESCRIBED USING THE CORRECT STRIPS, CORRECT UNIT OF MEASURE IN THE METER, USING APPROPRIATE TESTING TECHNIQUE AND NO KNOWN INFORMATION OF MISUSE. REPLACEMENTS PRODUCTS WERE SENT TO THE PATIENT. THE PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THIS COMPLAINT IS BEING RULED OUT AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION(S): ALTHOUGH THE PATIENT SELF TREATED FOR SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA WITH FOOD AND DRINK, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF TREATMENT DUE TO THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3132042

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR