BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2020635 · Received March 16, 2011

    Report

    Report Number
    2939301-2011-02285
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) K073231. 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) 2011 ALLEGING THAT HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING ON HIS ONE TOUCH ULTRALINK METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT THE PATIENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE PATIENT CLAIMED THAT HE WOULD INTERMITTENTLY OBTAIN BLOOD GLUCOSE READINGS ON HIS METER; HOWEVER, NOT ALL THE TIME. THE ALLEGED ISSUE WITH THE METER BEGAN A MONTH AGO. DUE TO THE ALLEGED ISSUE, HE CLAIMS HE WAS ADMITTED IN THE HOSPITAL FOR A BLOOD GLUCOSE RESULT OF 1,000 MG/DL AND SEVERE VOMITING ON (B)(6) 2011. PATIENT WAS TREATED WITH IV GLUCOSE. HE CLAIMS THAT PRIOR TO THE SYMPTOMS, HE DID NOT FEEL DIFFERENTLY PHYSICALLY AND FELT IT WAS NOT NECESSARY TO TEST HIS BLOOD GLUCOSE. WHILE THE PATIENT WAS IN THE HOSPITAL HE OBTAINED THE FOLLOWING READINGS ON THE HOSPITAL DEVICE, "294, 330, 267, 214, 134, 99, 282, 416, 302 AND 203 MG/DL". CUSTOMER SERVICE CARE ADVOCATE (CCA) SPOKE TO THE NURSE AND SHE MENTIONED THAT THE PATIENT WAS TESTING IN THE SET UP MODEL; THEREFORE, HE WAS UNABLE TO OBTAIN BLOOD GLUCOSE READINGS ON A REGULAR BASIS. CCA ASSISTED THE NURSE TO SET THE METER CORRECTLY AND ISSUE WAS RESOLVED VIA TROUBLESHOOTING. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ISSUE HE WAS UNABLE TO TEST DUE TO BEING IN THE SET UP MODE AND LATER DEVELOPED SYMPTOMS AND WAS HOSPITALIZED FOR A BLOOD GLUCOSE OF 1000MG/DL.

    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 47 YR Hospitalization| L| R