BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI ENHANCED METER

    MDR report key: 2197647 · Received August 9, 2011

    Report

    Report Number
    2939301-2011-07054
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. 510K #K043197.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(6) 2011 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE METER WAS RETURNED ON (B)(6) 2011 WHILE THE TEST STRIPS WERE RETURNED ON (B)(6) 2011.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH ULTRAMINI ENHANCE IS GIVING AN UNSPECIFIED "ERROR" MESSAGE. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE. THE PATIENT'S DIABETES IS MANAGED WITH INSULIN, NO SLIDING SCALE REGIMEN. THE PATIENT TAKES A SET AMOUNT OF INSULIN 4 TIMES PER DAY. ON THE MORNING OF (B)(6) 2011, THE PATIENT TESTED AT "3.9 MMOL/L" (70 MG/DL) ON THE SUBJECT METER. AROUND NOONTIME, THE PATIENT ATTEMPTED TO OBTAIN A BLOOD GLUCOSE READING BUT REPORTEDLY GOT THE "ERROR" MESSAGE. THE PATIENT ADMITTED SHE INSERTED THE TEST STRIP WITHOUT ANY BLOOD INTO THE SUBJECT METER WHICH MAY HAVE CAUSE THE ERROR MESSAGE. TWO HOURS LATER, SHE REPORTEDLY DEVELOPED SYMPTOMS OF "SHAKING, DIZZY, NAUSEOUS, AND BLURRED VISION." THE PATIENT RECEIVED PHONE ADVICE FROM HER NURSE TO DRINK SOME JUICE. THE PATIENT REPORTEDLY ADMINISTERED SELF TREATING WITH JUICE. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED DUE TO USER ERROR AND BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF ACUTE COMPLICATION OF DIABETES AFTER THE LFS METER GAVE AN "ERROR" MESSAGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3139764

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R