BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1901844 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-10060
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 31, 2010
    Report Date
    November 1, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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. 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS NOT ABLE TO REACH THE PATIENT BY PHONE FOR A FOLLOW UP CALL ON (B)(6) 2010 SINCE THE PATIENT DOES NOT HAVE A PHONE NUMBER PROVIDED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ISSUE BEGAN ON THE EVENING OF (B)(6) 2010 AT AN UNSPECIFIED TIME. THE PATIENT REPORTED SHE OBTAINED ALLEGED READINGS OF "390 AND 250 MG/DL" WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). THE CCA DOCUMENTED THAT THE PATIENT EXERCISED BUT IT IS NOT CLEAR WHEN THE ACTION WAS TAKEN. WITHIN AN HOUR AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE BECAME SHAKY, SWEATY, AND WEAK. THE PATIENT HOWEVER DENIED RECEIVING ANY MEDICAL TREATMENT AS A RESULT OF THE ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY AN APPROVED SAMPLE SITE WAS USED AND THE SUBJECT METER¿S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. IT IS NOT KNOWN IN THE DOCUMENTATION WHETHER THE PATIENT ASSOCIATED THE ALLEGED SYMPTOMS AS HIGH OR LOW BLOOD SUGAR SYMPTOMS OR WHETHER HE WAS ABLE TO TEST ON ANOTHER METER AFTER THE ALLEGED ISSUE BEGAN. THEREFORE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    THE LAY REPORTER/ WIFE CONTACTED LFS ON (B)(6) 2010 ALLEGING THAT HER HUSBAND'S METER WOULD NOT POWER ON. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED BY THE PATIENT'S WIFE ON (B)(6) 2010: THE PATIENT MENTIONED THAT THE METER WOULD NOT POWER ON; HOWEVER, DID NOT PROVIDE THE DATE AND TIME THE ALLEGED ISSUE BEGAN. THE PATIENT MENTIONED THAT DUE TO THE ALLEGED ISSUE, AT AN UNSPECIFIED TIME LATER, HE HAD SYMPTOMS OF FEELING TIRED, WEAK, THIRSTY AND NERVOUS. A NON-HCP TREATED HIM WITH FOOD/ AND DRINK AND THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THE METER DID NOT POWER ON BY PRESSING THE POWER BUTTON AND THE BATTERIES DID NOT NEED TO BE REPLACED. THE ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE METER NOT WORKING, THE PATIENT WAS UNABLE TO TEST AND DEVELOPED SYMPTOMS AND HAD TO BE TREATED BY A NON-HCP WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3054318

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening