BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3623660 · Received February 12, 2014

    Report

    Report Number
    2939301-2014-03435
    Event Type
    Injury
    Date Received
    February 12, 2014
    Report Date
    February 8, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2014) . THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. FURTHER, A DHR (DEVICE HISTORY RECORD) WAS COMMENCED ON (B)(6) 2014 FOR THIS PRODUCT AND NO PROCESS OR PRODUCT DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. ADDITIONALLY, PERFORMANCE TESTING WITH BLOOD WAS PERFORMED ON THE RETAIN TEST STRIPS ON (B)(6) 2014. THE RETAIN TEST STRIPS PASSED THE PERFORMANCE TESTING WITH BLOOD. 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)(6) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN AT THE END OF DECEMBER (YEAR NOT SPECIFIED). THE PATIENT REPORTED SEVERAL RESULTS OF ¿150, 216, 135, 169, 185, 211, 156, 167, 164, 174, 166, 157, 189, 133, 182 AND 173 MG/DL¿ WITH THE SUBJECT METER (PERFORMED AT UNSPECIFIED TIMES). THE PATIENT MANAGES HIS DIABETES WITH INSULIN (30 UNITS IN THE MORNING AND 40 UNITS IN THE EVENING), METFORMIN PILLS AND WELCHOL PILLS. THE PATIENT CONTINUED TO FOLLOW HER USUAL MANAGEMENT ROUTINE. ONE DAY AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF SHAKY AND NAUSEOUS. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91796 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3557386

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening