BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5390077 · Received January 26, 2016

    Report

    Report Number
    2939301-2016-03755
    Event Type
    Injury
    Date Received
    January 26, 2016
    Report Date
    January 13, 2016
    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
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1. THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, LIFESCAN CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. 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) 2016, THE PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRA2 METER HAD BEEN READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT, DESPITE NUMEROUS ATTEMPTS, TO OBTAIN FURTHER INFORMATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY OCCURRED AT AN UNSPECIFIED TIME ON (B)(6) 2015. AT THIS TIME THE PATIENT ALLEGED TO HAVE OBTAINED BLOOD GLUCOSE READINGS OF ¿145, 190, 170 AND 175MG/DL¿ WITH THE SUBJECT METER WITHIN 20 MINUTES OF ONE ANOTHER. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (1000MG METFORMIN PER DAY) AS WELL AS WITH AN UNSPECIFIED TYPE AND DOSAGE OF INSULIN. THE PATIENT DENIED MAKING ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED INACCURACY. THE PATIENT STATED THAT 2 HOURS PRIOR TO THE ALLEGED PRODUCT ISSUE OCCURRING THEY DEVELOPED THE SYMPTOMS OF ¿WEAKNESS, FATIGUE AND SHAKINESS¿; HOWEVER IT IS NOT KNOWN WHETHER THEY RECEIVED ANY FORM OF TREATMENT AS A RESULT OF THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, AND THE SAMPLES WERE TAKEN FROM AN APPROVED SAMPLE SITE. THE PATIENT¿S PRODUCTS WERE REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS TO HAVE OBTAINED INACCURATELY ERRATIC READINGS ON THE SUBJECT METER WHICH MAY HAVE CAUSED/CONTRIBUTED TO THE FACT THAT THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SERIOUS INJURY. IT CANNOT BE SAID WITH ABSOLUTE CERTAINTY THAT THE ALLEGED ¿INACCURATELY ERRATIC¿ SUBJECT METER RESULTS DID NOT AFFECT TREATMENT OPTIONS PRIOR TO SYMPTOMS DEVELOPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48980 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3861795

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening