BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 2213612 · Received August 16, 2011

    Report

    Report Number
    2954323-2011-04222
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    October 18, 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

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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 (FIELD ACTION REFERENCE NUMBER 2954323-12/22/10-001-R). ALL AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING (B)46) 2010. THE MANUFACTURE DATE OF THE TEST STRIP WITH LOT NUMBER 45675 WAS ON (B)(4) 2010.. THE MANUFACTURE DATE OF THE TEST STRIP WITH LOT NUMBER 46009 WAS ON (B)(4) 2010.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOTS REPORTED BY THE CUSTOMER (45675 AND 46009) WERE TESTED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT BACK WHEN SHE RECEIVED THE ADC RECALLED TEST STRIPS (LAST SPRING) SHE GOT REALLY SICK, BUT HER TEST RESULTS ON THE ADC BLOOD GLUCOSE METER HAD BEEN IN THE FINE RANGE. CUSTOMER STATED SHE GOT REALLY, REALLY SICK AND THOUGHT IT WAS FLU SYMPTOMS; SHE WAS HOSPITALIZED TWICE AND THE DOCTOR SAID SHE WAS IN KETOACIDOSIS. HE SAID HER DIABETES WAS OUT OF CONTROL, BUT SHE DID NOT BELIEVE HIM BECAUSE HER RESULTS HAD BEEN IN THE IN CONTROL RANGE. CUSTOMER STATED SHE NOW KNOWS THAT WAS DUE TO THE TEST STRIP RECALL. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT'S PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED EITHER LONGER BLOOD FILL TIME OR READING ISSUES. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 45675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other