BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4242197 · Received November 11, 2014

    Report

    Report Number
    2939301-2014-30219
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    November 2, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO A HAEMOGLOBIN A1C LABORATORY RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. IT IS NOT KNOWN WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE READING OF ¿106 MG/DL¿ WITH THE SUBJECT METER AND A HAEMOGLOBIN A1C RESULT OF ¿8.4¿. LFS DOES NOT CONSIDER THIS TO BE A VALID COMPARISON. THE PATIENT MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS). THE PATIENT STATED SHE DECREASED HER DOSE OF INSULIN BY HALF AT 5:00PM ON AN UNSPECIFIED DATE IN RESPONSE TO THE ALLEGED INACCURACY ISSUE. IT IS NOT KNOWN IF THE PATIENT DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ISSUE HOWEVER THE PATIENT REPORTED ATTENDING THE EMERGENCY ROOM AT AN UNSPECIFIED DATE AND TIME AFTER THE ALLEGED ISSUE BEGAN WHERE SHE RECEIVED HEALTH CARE PROFESSIONAL (HCP) TREATMENT OF FOOD AND/OR DRINK. THE PATIENT STATED A BLOOD GLUCOSE READING WAS TAKEN ON ANOTHER DEVICE AT AN UNSPECIFIED DATE AND TIME HOWEVER THE RESULT IS UNKNOWN. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED HCP TREATMENT FOR A LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725092 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3537864

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R