BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3000521 · Received March 12, 2013

    Report

    Report Number
    3008382007-2013-04683
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2013, AT 12:30PM SHE OBTAINED AN ALLEGED INACCURATE HIGH READING OF "354 MG/DL" WITH THE SUBJECT METER. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN. IN RESPONSE TO THE HIGH READING, THE PATIENT CLAIMED SHE ADMINISTERED TO HERSELF 20 UNITS OF HUMALOG INSULIN. APPROXIMATELY 15 MINUTES AFTER ADMINISTERING THE INSULIN, THE PATIENT REPORTED DEVELOPING SYMPTOMS SWEATY AND RAPID HEARTBEAT. AT THE ONSET OF SYMPTOMS, THE PATIENT TESTED HER BLOOD GLUCOSE AND OBTAINED A READING OF "60 MG/DL." THE PATIENT STATED SHE TREATED HERSELF WITH 2 GLUCOSE TABLETS IN RESPONSE TO THE LOW SYMPTOMS AND CONFIRMED FEELING BETTER AFTERWARDS. THE PATIENT MENTIONED SHE RETESTED AGAIN AFTER TREATING SELF WITH THE GLUCOSE TABLETS AND HER BLOOD GLUCOSE WAS "90 MG/DL." AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT PATIENT DID NOT HAVE THE SUBJECT METER OR TESTING SUPPLIES WITH HER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103336 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R