BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3926348 · Received July 10, 2014

    Report

    Report Number
    2939301-2014-17013
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A DATE/TIME ISSUE WITH THE ONE TOUCH ULTRA 2 METER. THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2014, AT 7:31 P. M., THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE), DIET, AND EXERCISE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT STATED, IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿BLURRY VISION¿. THE PATIENT STATED SHE CONTACTED HER HEALTH CARE PROFESSIONAL (HCP) AND THEY ¿HELPED HER SET UP THE DATE/TIME ON THE METER¿. THE PATIENT MENTIONED, AT AN UNSPECIFIED TIME ON (B)(6) 2014, HER BLOOD GLUCOSE WAS TESTED ON ANOTHER DEVICE (UNKNOWN TYPE), BUT SHE DID NOT PROVIDE THE ACTUAL READING(S) OBTAINED AT THE TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS THE FIRST TIME THE PATIENT USED THE SUBJECT METER. THE CCA WALKED THE PATIENT THROUGH A RETEST AND THE ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. BASED ON THE PROVIDED INFORMATION AT THIS TIME, IT IS UNCLEAR HOW THE DATE/TIME FORMAT ISSUE CAN LEAD TO THE PATIENT¿S SYMPTOMS SINCE THE DATE/TIME SETTING DOES NOT AFFECT THE ABILITY TO TEST. 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 BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA (BLURRY VISION) AFTER THE DATE/TIME ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404429 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3482113

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening