BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4250945 · Received November 14, 2014

    Report

    Report Number
    2939301-2014-30693
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    November 6, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 # 2 ¿ (12/29/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 12/17/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/17/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHEN THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/15/2014).THE PATIENT¿S METER HAS BEEN RETURNED ON 12/3/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/5/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT DURING A FOLLOW-UP TELEPHONE CALL. THE PATIENT STATED THAT THE ALLEGED INACCURATE HIGH BEGAN WHEN HE STARTED USING THE METER FOR THE FIRST TIME APPROXIMATELY 2 MONTHS BEFORE CONTACTING LIFESCAN. THE PATIENT STATED THAT HE HAD BEEN OBTAINING READINGS WITH THE SUBJECT METER AS HIGH AS "260-265 MG/DL" ALMOST DAILY, COMPARED TO FEELINGS/NORMAL RESULTS, SINCE THE ALLEGED INACCURATE HIGH BEGAN. THE PATIENT MANAGES HIS DIABETES WITH SELF-ADJUSTING INSULIN. THE PATIENT STATED THAT HE HAD REDUCED HIS USUAL DAILY DOSE OF 20 UNITS OF INSULIN DOWN TO AS LITTLE AS 5 UNITS DAILY IN RESPONSE TO THE ALLEGED INACCURATE HIGH READINGS; HOWEVER, THE SUBJECT METER WAS STILL READING HIGH. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOMS OF "SHAKY, COLD AND CLAMMY" ALMOST DAILY SINCE THE ALLEGED INACCURATE HIGH BEGAN. THE PATIENT STATED THAT ON SOME OCCASIONS HE WOULD SELF-TREAT WITH MORE FOOD/DRINK. AT THE TIME OF INITIAL TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, THE TEST STRIPS HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE AND THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A WALK-THROUGH TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED AS THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF ¿SHAKY¿ AFTER THE ALLEGED INACCURATE HIGH BEGAN. THIS SYMPTOM DOES MEET LIFESCAN¿S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738012 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3657015

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening