BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION XTRA

    MDR report key: 2032989 · Received March 29, 2011

    Report

    Report Number
    2954323-2011-02704
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 29, 2011
    Product Code
    NBW
    Removal / Correction Number
    ADC FA1197-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN SAMPLES OF PRECISION TEST STRIP LOTS MANUFACTURED WITH HOT-MELT GLUE BATCHES EXHIBITED LOWER THAN EXPECTED READINGS ON CONTINUOUS STORAGE AFTER NINE MONTHS AT 30 DEGREES CELSIUS DURING ROUTINE STABILITY PERFORMANCE TESTING. THIS STABILITY ISSUE COULD LEAD TO THE GENERATION OF INCORRECTLY DEPRESSED BLOOD GLUCOSE RESULTS AND THESE ERRONEOUS RESULTS MAY BE IN THE "C", "D" OR "E" ZONES OF PARKES ERROR GRID, AND AS SUCH, HAVE THE POTENTIAL TO BE CLINICALLY SIGNIFICANT. THE PRIMARY CAUSE HAS BEEN IDENTIFIED TO BE BATCH TO BATCH GLUE VARIABILITY. THE FDA HAS BEEN INFORMED OF THE FIELD ACTION PER 21CFR806 (B)(4). ALL AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING (B)(4), 2010. THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. MULTIPLE, UNSUCCESSFUL, ATTEMPTS TO CONTACT THE FAMILY MEMBER HAVE BEEN MADE IN AN ATTEMPT TO GATHER INFORMATION REGARDING THE METER SERIAL NUMBER, THE TEST STRIP LOT NUMBER, WHETHER THE CUSTOMER HAD ATTEMPTED TO TEST USING ADC PRODUCTS PRIOR TO HER HOSPITALIZATION AND INFORMATION REGARDING THE ACTUAL CAUSE OF DEATH. NOTE: THE DATE OF MANUFACTURE IS UNKNOWN. ADDITIONALLY, CUSTOMER'S FAMILY MEMBER INDICATED THIS OCCURRED IN (B)(6), 2011.

    Description of Event or Problem · 1

    A CUSTOMER'S FAMILY MEMBER CALLED CUSTOMER SERVICE ON (B)(6), 2011 TO INQUIRE WHEN THE MALFUNCTION RELATED TO PRECISION FAMILY TEST STRIPS WAS IDENTIFIED BY ABBOTT DIABETES CARE. SHE FURTHER NOTED SHE HAD JUST RECEIVED THE NOTIFICATION LETTER AND PROCEEDED TO REPORT THE FOLLOWING INFORMATION: CALLER NOTED THAT TWO MONTHS PRIOR TO CALLING, HER MOTHER (CUSTOMER) WAS RUSHED TO THE HOSPITAL WHERE A READING OF 33 MG/DL WAS RECEIVED ON AN UNKNOWN BRAND OF METER. SHE FURTHER REPORTED CUSTOMER HAD "JUST RECENTLY PASSED AWAY". CALLER INDICATED THE DEATH OCCURRED "IN (B)(6)". CALLER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION, EXCEPT TO NOTE THAT SHE WAS NOT IMPLYING HER MOTHER'S DEATH WAS RELATED TO THE PRODUCT RECALL. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING AFFECTED TEST STRIPS AT THE TIME OF THE REPORTED VISIT TO THE HOSPITAL OR ANY INFORMATION REGARDING CUSTOMER'S RECENT DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death