BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2180657 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06500
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. AT AN UNSPECIFIED TIME AND DATE IN (B)(6) 2010, THE CCA WAS ADVISED BY THE PATIENT THAT SHE DEVELOPED SYMPTOMS OF "CONFUSION AND ANGER" AND IMMEDIATELY AFTER, DISCOVERED THAT THE SUBJECT METER WAS ALLEGEDLY NOT TURNING ON. THE PATIENT STATED THAT SHE TAKES INSULIN (UNKNOWN TYPE AND DOSAGE) TO MANAGE HER DIABETES AND TOOK HER USUAL DOSE OF MEDICATIONS ON A DAILY BASIS IN RESPONSE TO THE REPORTED ISSUE. AT AN UNSPECIFIED DATE AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE CALLED THE EMS AND AT THE TIME OF THE CALL, EXPERIENCED "LOW BLOOD SUGAR SYMPTOMS". THE PATIENT REPORTED BEING TREATED WITH "APPLE JUICE" AND "GLUCOGAN INJECTION" IN RESPONSE TO THE SYMPTOMS. THE CCA ALSO NOTED THAT THE PATIENT WAS TESTED ON AN UNKNOWN DEVICE AND OBTAINED "LOW BLOOD READINGS". AT THE TIME OF TROUBLESHOOTING, AFTER THE CCA WALKED THE PATIENT THROUGH THE RECOMMENDED USAGE PER THE OWNER'S BOOKLET, THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE REPORTED METER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3126840

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention