BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI ENHANCED METER

    MDR report key: 2190232 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06827
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRAMINI METER WAS GIVING HER INACCURATE ERRATIC READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2011 AT AROUND 7:00AM, THE REPORTER INFORMED THE CCA THAT THE PATIENT REPORTED THE FOLLOWING BLOOD GLUCOSE RESULTS: "9PM 252MG/DL, 430PM 250MG/DL, 1130AM 244MG/DL, 2PM 393MG/DL, AND 8AM 135MG/DL" WITH THE SUBJECT METER. THE REPORTER STATED THAT THE PATIENT TAKES INSULIN (UNKNOWN TYPE AND DOSAGE) TO MANAGE HER DIABETES. ON (B)(6) 2011 AT 9:00PM, THE REPORTER STATED THAT SHE ADMINISTERED 12 UNITS OF NOVOLOG INSTEAD OF THE PATIENT'S NORMAL DOSAGE OF 6 UNITS PER THE DOCTOR'S ADVICE AND BY 11:00PM THAT NIGHT, THE PATIENT STARTED DEVELOPING SYMPTOMS OF "SWEATING, FOAMING OF THE MOUTH, EYES ROLLING BACK, STIFFNESS AND SHAKING". HALF AN HOUR LATER, THE REPORTER CLAIMED TO HAVE BROUGHT THE PATIENT TO THE ER WHERE THE PATIENT WAS TESTED ON THE ER'S METER AND OBTAINED A READING OF "9MG/DL" AND SHORTLY AFTER, AT MIDNIGHT, WAS GIVEN IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3157321

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening