BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4191636 · Received October 22, 2014

    Report

    Report Number
    2939301-2014-28328
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 16, 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) USA ALLEGING THAT HIS ONE TOUCH ULTRA2 METER HAD A POWER ISSUE ¿ UNIT TURNS OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE FIRST OCCURRED ON (B)(6) 2014 AT AN UNSPECIFIED TIME. THE PATIENT STATED HE WAS TAKING INSULIN (SELF-ADJUSTER) AS HIS DIABETES MEDICATIONS AT THE TIME OF THE PRODUCT ISSUE AND TOOK NO ACTION TO HIS REGULAR DIABETES MANAGEMENT REGIMEN ROUTINE AS A RESULT OF THE POWER ISSUE. ON (B)(6) 2014 AT 11PM, THE PATIENT ALLEGED TO DEVELOP SYMPTOMS OF ¿SWEATY AND PALE¿, AND ON THE SAME DAY AT 11:05PM HE SELF-TREATED WITH FOOD AND/OR DRINK AS TREATMENT FOR THE SYMPTOM. CCA NOTED THAT PATIENT ¿DEVELOPED SYMPTOMS DUE TO NOT BEING ABLE TO TEST FOR A WHILE AND TAKING INSULIN ANYWAYS¿. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THERE WAS NO MISUSE OF THE PRODUCT, AND IT WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. CCA NOTED THAT BASED ON THE INFORMATION PROVIDED THE METER¿S BATTERIES SHOULD HAVE BEEN RENEWED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED; THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: BASED ON THE INFORMATION PROVIDED, THE PATIENT DID SUFFER SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THE ALLEGED PRODUCT ISSUE WITH THE LFS DEVICE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673510 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3684571

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening