BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRASMART METER

    MDR report key: 4183453 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27912
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Report Date
    October 12, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (10/21/2014) -CORRECTION: TYPE OF REPORTABLE EVENT CHECKED AS MALFUNCTION AS THIS INFORMATION WAS MISSING FROM INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT¿S MOTHER CONTACTED LIFESCAN (LFS) USA, ON BEHALF OF THE PATIENT, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRASMART METER WOULD NOT TURN ON. THE REPORTER ALSO REPORTED THAT AFTER THE POWER ISSUE BEGAN THEY DISCOVERED THAT THE SUBJECT METER¿S BATTERY CONTACTS WERE CORRODED. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE REPORTER. DURING THE FOLLOW-UP CALL, THE REPORTER STATED THAT ON (B)(6) 2014 AT AROUND 3:00 TO 4:00PM, THE PATIENT BEGAN ¿THROWING UP¿. IN RESPONSE TO THIS SYMPTOM, THE PATIENT ATTEMPTED TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER AT 7:00PM BUT ALLEGED THE METER WOULD NOT TURN ON. THE REPORTER CONFIRMED THE PATIENT WAS NOT ABLE TO OBTAIN ANY READINGS ON THE SUBJECT METER DUE TO THE ALLEGED POWER ISSUE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED METER ISSUE. THE REPORTER HOWEVER CLAIMED THAT AS A RESULT OF NOT BEING ABLE TO TEST AND BECAUSE OF THE REPORTED SYMPTOM, THE PATIENT ATTENDED THE EMERGENCY ROOM AT AN UNSPECIFIED TIME THAT EVENING WHERE HE WAS DIAGNOSED WITH HAVING DEVELOPED ¿KETOACIDOSIS¿. THE REPORTER STATED THE PATIENT WAS TREATED WITH IV SALINE AROUND 9:00 TO 10:20PM THAT EVENING AND WAS DISCHARGED FROM HOSPITAL A COUPLE OF DAYS LATER. DURING THE FOLLOW-UP CALL, THE REPORTER STATED THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN (SLIDING SCALE) AND IT WAS DOCUMENTED THAT HE TESTS HIS BLOOD GLUCOSE FOUR TIMES A DAY. THE PATIENT¿S NORMAL BLOOD GLUCOSE RANGE IS ¿80-120 MG/DL¿. PRIOR TO THE ONSET OF THE REPORTED ISSUES WITH THE SUBJECT METER, THE REPORTER CLAIMED THE PATIENT HAD LAST TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER POSSIBLY A COUPLE OF DAYS PRIOR. THE REPORTER CLAIMED THE READING WAS ¿86 MG/DL¿ AND WAS WITHIN HIS NORMAL RANGE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE LFS PRODUCT, THERE WAS NO INDICATION OF MISUSE AND THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING. THE CSR DOCUMENTED THAT THE METER TURNED ON WHEN THE TEST STRIP THAT PREVIOUSLY DID NOT TURN METER ON WAS INSERTED AND WHEN THE POWER BUTTON WAS PRESSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY TREATED FOR DIABETIC KETOACIDOSIS AFTER HE WAS UNABLE TO TEST WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664108 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3598194

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| L| R