BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3894092 · Received June 25, 2014

    Report

    Report Number
    2939301-2014-15429
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 18, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/08/2014). DEVICE EVALUATION:THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON 08/28/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 09/02/2014 WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW BATTERY VOLTAGE.IN ADDITION, THE METER WAS FOUND TO HAVE EEPROM U6 CORRUPTION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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, A THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH ULTRA 2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT¿S DAUGHTER ON (B)(6) 2014. THE DAUGHTER REPORTED THAT THE ALLEGED POWER ISSUE BEGAN THE MORNING OF (B)(6) 2014. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN) AND INSULIN (HUMALOG, UNKNOWN DOSAGE). THE REPORTER STATED THAT HER MOTHER CONTINUED WITH HER USUAL DOSE OF MEDICATION (UNKNOWN TYPE AND DOSAGE) IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER STATED, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿SLURRED LANGUAGE, COULDN¿T STAND STRAIGHT, LOST USE OF LEFT HAND, AND HAD A STROKE¿. THE REPORTER BROUGHT THE PATIENT TO THE EMERGENCY ROOM (ER) AND STATED HER BLOOD GLUCOSE WAS TESTED AND OBTAINED A READING ¿IN THE 200S, LIKE 270 OR 280 MG/DL¿ WITH THE ER/HOSPITAL METER. THE REPORTER STATED A HEALTH CARE PROFESSIONAL (HCP) TREATED THE PATIENT WITH AN ¿IV¿, BUT DOES NOT RECALL THE TYPE IV THAT WAS GIVEN. THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR ¿3 DAYS¿. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE PATIENT USED THE METER AND THERE WAS NO MISUSE OF THE PRODUCT. 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
    371128 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 2704543

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R