BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4151836 · Received October 8, 2014

    Report

    Report Number
    2939301-2014-26802
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    October 1, 2014
    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
    NM, 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'S SON (THE REPORTER) CONTACTED LIFESCAN USA ALLEGING THAT THE PATIENT'S ONETOUCH ULTRAMINI METER DISPLAYED AN ERROR MESSAGE. THIS COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE REPORTER STATED THAT THE ERROR MESSAGE BEGAN ON (B)(6) 2014 AT 8 AM. THE REPORTER STATED THAT HE TESTED HIS MOTHER'S BLOOD GLUCOSE USING THE SUBJECT METER TWICE THAT MORNING AND THE METER DISPLAYED AN UNKNOWN ERROR MESSAGE BOTH TIMES INSTEAD OF A RESULT. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF MEDICATIONS WITH DIET AND/OR EXERCISE. THE REPORTER STATED THAT HE GAVE THE PATIENT 15 UNITS OF INSULIN IN RESPONSE TO THE ALLEGED ERROR MESSAGE. THE REPORTER CLAIMED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS; HOWEVER HE CALLED FOR AN AMBULANCE AT 8 AM ON THE SAME DAY. THE EMS TESTED THE PATIENT'S BLOOD GLUCOSE AND SHE WAS ALSO TESTED AT ER AND THE RESULTS OBTAINED WERE "107-227 MG/DL" (TIMES UNKNOWN). THE REPORTER STATED THAT THE PATIENT WAS TAKEN TO HOSPITAL BY EMS AND TREATED IN ER WITH IV FLUIDS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT AND REPORTER WERE AT THE ER SO WERE UNABLE TO PERFORM WALK-THROUGH TROUBLESHOOTING AS THEY DID NOT HAVE THE TEST STRIPS AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: EVEN THOUGH THE REPORTER CLAIMED THAT THE PATIENT DID NOT DEVELOP SYMPTOMS, THE PATIENT RECEIVED HCP TREATMENT AT ER SUGGESTIVE OF A SEVERE LOW OR HIGH BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632690 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R