BEUDAMED
    FDA Adverse Event Summary report: N

    OT ULTRA2 METER

    MDR report key: 4339463 · Received December 18, 2014

    Report

    Report Number
    2939301-2014-34894
    Date Received
    December 18, 2014
    Report Date
    December 11, 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
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PLEASE REFER TO (B)(4) (INACCURATE HIGH) FOR ACTUAL MDR SUBMISSION RELATED TO THIS COMPLAINT. "ON (B)(6) 2014, LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) AND ALLEGED THEIR ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE PATIENT ALSO ALLEGED AN INACCURATE LOW ISSUE COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS, A DATE/TIME ISSUE AND A METER DOES NOT TURN ON ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ISSUES BEGAN AT THE END OF (B)(4). THE PATIENT ALLEGED THEY OBTAINED INACCURATE HIGH RESULTS OF ¿208, 183, 197, 187 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT ALSO ALLEGED OBTAINING INACCURATE LOW RESULTS IN THE 30S AND 40S WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). THE PATIENT CONFIRMED THAT SHE DID MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE; THE PATIENT ALLEGED AN INCREASE IN MEDICATION ON (B)(6) 2014 AT AN UNKNOWN TIME, THE PATIENT REPORTED HER DOCTOR PRESCRIBED ADDITIONAL ¿ACTOSE¿ TO HER NORMAL ROUTINE. THE PATIENT CLAIMS SHE DEVELOPED SYMPTOMS OF ¿QUEASY, LOW BLOOD SUGAR, SHAKING, NAUSEA, DIZZY¿ A WEEK OR TWO AFTER THE PRODUCT BEGAN. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT DUE TO THE PRODUCT ISSUE. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE TEST STRIPS WERE NOT OPEN PAST THEIR DISCARD OR EXPIRY DATES AND THE TEST STRIPS WERE STORED CORRECTLY. THE CCA WAS UNABLE TO WALK THROUGH A RETEST AS PATIENT DID NOT HAVE CONTROL SOLUTION. THE CCA WAS ABLE TO RESOLVE THE DATE/TIME ISSUE WITH TRAINING AND WAS ABLE TO RESOLVE THE DOES NOT TURN ON ISSUE WITH A NEW BATTERY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SEVERE LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED PRODUCT ISSUE BEGAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830558 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3596388

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R