BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1961759 · Received January 14, 2011

    Report

    Report Number
    2939301-2011-00486
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 7, 2010
    Report Date
    December 18, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    THE 510 (K) # IS K073232. 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING A COMMUNICATION ISSUE WITH HER ULTRALINK METER AND THE MEDTRONIC DEVICE. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL CALL. THE PATIENT MENTIONED THAT ON THE MORNING OF (B)(6) 2010, HAD TESTED ON HER ULTRALINK METER AND NOTICED THE BLOOD GLUCOSE READING DID NOT TRANSFER TO HER MEDTRONIC DEVICE. IT IS UNKNOWN AT THIS TIME WHAT HER BLOOD GLUCOSE READING WAS ON THE ULTRALINK METER. THE PATIENT WENT TO EXERCISE AND AT AN UNSPECIFIED TIME LATER, THE PATIENT WAS VOMITING, "NAUSEA, KETONES AND ASATONS" THE PATIENT WENT TO THE ER AND WAS TESTED ON ANOTHER DEVICE AND OBTAINED A RESULT IN THE 200'S AND WAS TREATED WITH IV FLUIDS. IT WAS ALSO NOTED THAT IN THE ER THE PATIENT ALSO HAD "BAD PUMP SITES". CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO RESOLVE THE ISSUE AND SENT THE PATIENT A REPLACEMENT METER. BASED ON THE PROVIDED INFORMATION AT THIS TIME, IT IS UNCLEAR HOW THE BLOOD GLUCOSE READING RESULT WAS NOT SENT TO THE MEDTRONIC DEVICE CAN LEAD TO THE PATIENT'S SYMPTOMS SINCE THE COMMUNICATION ISSUE METER THE LFS METER AND THE MEDTRONIC DOES NOT AFFECT THE ABILITY TO TEST. PATIENT IS ABLE TO TEST ON THE METER AND VIEW THE RESULT. THUS, THE LINKAGE BETWEEN THE REPORTED PRODUCT ISSUE AND THE ALLEGED INJURIES BY THE PATIENT REMAINS UNCLEAR. DESPITE REPEATED ATTEMPTS, THE PATIENT COULD NOT BE CONTACTED FOR FURTHER INFORMATION. IN CONCLUSION, THIS COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    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 29 YR