BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3231908 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-20149
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 25, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (08/22/2013). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 8/9/2013 AND 8/2/2013, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/14/2013 AND 8/7/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND.THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE TEST STRIPS WERE ALSO EVALUATED AND WERE FOUND TO GIVE RESULTS ABOVE THE CONTROL SOLUTION 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO REACH THE LAY USER/ PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN APPROXIMATELY IN THE FIRST WEEK OF JUNE. HE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF ¿169 MG/DL¿ AS COMPARED TO A LAB VALUE OF ¿60 MG/DL¿ (FASTING) AS WELL AS ¿279 MG/DL¿ WITH THE SUBJECT METER AS COMPARED TO A LAB VALUE OF ¿160 MG/DL¿ (POSTPRANDIAL). BOTH COMPARISONS WERE MADE WITHIN 10 MINUTES. THE PATIENT MANAGES HIS DIABETES WITH ZORYL MP 2, (GLIMEPIRIDE) AND MIGNAR 2.5. (MIGLITOL) TWICE PER DAY, IN THE MORNING AND EVENING AND REPORTED THAT HE WENT TO SEE HIS DOCTOR ALSO DURING THE 1ST WEEK OF (B)(6) AND HIS DOCTOR INCREASED HIS ORAL MEDICATION FROM 2 PILLS TO 3 PILLS IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT STATED HIS BLOOD GLUCOSE DID NOT IMPROVE AND HE WENT BACK TO THE DOCTOR ON AN UNKNOWN DATE/TIME AND THE DOCTOR FURTHER INCREASED HIS MEDICATION BY AN UNKNOWN AMOUNT. THE PATIENT CLAIMED HIS BLOOD GLUCOSE LEVELS DROPPED LOW AND HE HAD ¿HYPOGLYCEMIC ATTACKS¿ BUT HE DID NOT REPORT ANY READINGS OR ANY SPECIFIC SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. A CONTROL SOLUTION TEST WAS PERFORMED BUT THE READING DID NOT FALL WITHIN THE RANGE SPECIFIED ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED A LOW BLOOD GLUCOSE EXCURSION AND THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332295 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3325042

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening