BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3978469 · Received August 4, 2014

    Report

    Report Number
    2939301-2014-19554
    Event Type
    Injury
    Date Received
    August 4, 2014
    Report Date
    July 28, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/21/2014), THE PATIENT¿S METER HAS BEEN RETURNED ON 9/13/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/15/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH HIS ONE TOUCH ULTRA 2 METER TESTING IN SETTINGS MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2014. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (UNKNOWN DOSAGE), DIET AND EXERCISE AND DENIED TAKING ANY ACTION IN REGARDS TO HIS NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT STATED, A WEEK AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF AN ¿IRREGULAR HEARTBEAT, PALPITATIONS¿. AT AN UNSPECIFIED DATE/TIME, THE PATIENT STATED THAT HE WENT TO THE EMERGENCY ROOM (ER) AND HIS BLOOD GLUCOSE WAS TESTED WITH A DR/CLINIC METER AND OBTAINED READINGS OF ¿150, 143, 117 MG/DL.¿ THE PATIENT REPORTED THAT HE WAS TREATED WITH ¿BLOOD THINNER, XARELTO, AND CARTIA¿ BY A HEALTH CARE PROFESSIONAL (HCP). AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH A TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453158 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3644474

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R