BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3660396 · Received March 5, 2014

    Report

    Report Number
    2939301-2014-05259
    Event Type
    Injury
    Date Received
    March 5, 2014
    Report Date
    February 25, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 3 - (07/02/2014) - CORRECTIONFOLLOW-UP #2 INCLUDED INCORRECT SCRIPTING IN RELATION TO THE CODES PROVIDED. THE CORRECT SCRIPTING IS AS FOLLOWS: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. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHEN THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. TERTIARY, THE TEST STRIPS WERE FOUND TO BE CONTAMINATED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (06/04/2014). THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED, AND WERE EVALUATED ON 05/29/2014 BY LIFESCAN PRODUCT ANALYSIS 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (06/12/2014). THE LAY USER/PATIENT¿S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 06/09/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO BE CONTAMINATED AND TO HAVE RESULTS ABOVE AND BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. HOWEVER, RETAINED TEST STRIPS PASSED ALL TESTING ON 04/03/2014.ADDITIONALLY, A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 04/30/2014 AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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 A ONETOUCH ULTRA2 METER WAS READING INACCURATELY LOW COMPARED TO HIS FEELINGS OR NORMAL RESULTS. THE PATIENT WAS NOT AVAILABLE FOR A FOLLOW UP CALL. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED 3 WEEKS PRIOR TO CONTACTING LFS, HE OBTAINED READINGS OF ¿201, 181, 161, 198MG/DL¿ ON THE LFS METER. IT IS UNCLEAR HOW MUCH TIME PASSED IN BETWEEN THE READINGS. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED AT THE SAME TIME AS THE ALLEGED ISSUE, HE FELT SHAKY. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION. HOWEVER, NO CONTROL SOLUTION TEST WAS COMPLETED SINCE THE PATIENT DID NOT HAVE ANY TROUBLESHOOTING AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132548 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3482373

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening