BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4240534 · Received November 10, 2014

    Report

    Report Number
    2939301-2014-30202
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 31, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (12/18/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 11/24/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/5/2014 WITH THE FOLLOWING FINDINGS:ADDITIONAL TESTS WERE PERFORMED ON THE DESICCANT TO CHECK FOR POSSIBLE MOISTURE ISSUE. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO BE SATURATED BY MOISTURE AND FAILED TGA TESTING. 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 ¿ (11/26/2014). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 11/11/2014 AND 11/24/2014, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/13/2014 AND 11/25/2014, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS GREATER THAN +50% OF THE CONTROL SOLUTION WHEN TESTED WITH CONTROL SOLUTION. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL TO CHECK THE STRUCTURAL INTEGRITY. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. 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

    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)(4) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HER ONETOUCH ULTRA2 READ INACCURATELY HIGH. THIS COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE PATIENT STATED THAT THE ALLEGED INACCURATE HIGH BEGAN ON (B)(4) 2014 AT APPROXIMATELY 11 PM. THE PATIENT STATED THAT BEFORE BED, SHE OBTAINED A READING OF "108 MG/DL" FROM THE SUBJECT METER COMPARED TO FEELINGS/NORMAL RESULTS. THE PATIENT STATED THAT SHE FELT THIS WAS INACCURATELY HIGH AS SHE FELT THAT HER BLOOD GLUCOSE WAS MORE LIKE "40 MG/DL". THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN AND AN INSULIN PUMP. THE PATIENT CONFIRMED THAT SHE DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMED THAT SHE WOKE AT 1 AM THE FOLLOWING MORNING WITH THE SYMPTOM OF "HYPOGLYCEMIA". HER HUSBAND TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND A NEW VIAL OF TEST STRIPS AND OBTAINED A READING OF "72 MG/DL". WITHIN A FEW MINUTES, HE OBTAINED A SECOND READING OF "76 MG/DL", USING ANOTHER METER AND THE NEW TEST STRIPS. THE PATIENT STATED THAT HER HUSBAND PROVIDED TREATMENT WITH A GLUCAGON INJECTION. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (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 "HYPOGLYCEMIA", WHICH SHE ASSOCIATED WITH A SEVERE LOW BLOOD GLUCOSE EXCURSION, AFTER THE METER ISSUE BEGAN. THIS SYMPTOM DOES MEET LIFESCAN¿S CRITERIA FOR A SERIOUS INJURY. ADDITIONALLY, THE PATIENT RECEIVED TREATMENT FOR SUCH AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723622 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3557384

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R