BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1982987 · Received February 9, 2011

    Report

    Report Number
    2954323-2011-01562
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 15, 2011
    Report Date
    April 8, 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 INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. 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 30C 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 (FIELD ACTION REFERENCE NUMBER 2954323-12/22/10-001-R). ALL AFFECTED CONSIGNEES WERE NOTIFIED BY LETTER BEGINNING DECEMBER 22, 2010.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (XXXXXXX) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    PREVIOUS FOLLOWUP REPORT DID NOT MENTION THE TEST STRIP LOT NUMBER THAT WAS TESTED WITH CONTROL SOLUTION. THE CORRECTED INFORMATION IS AS CONTINUES. REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT'S PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED READINGS ISSUES. THE CUSTOMER REPORTED RECEIVING ERRATIC READINGS OF 20 MG/DL AND 127 MG/DL WITHIN 10 MINUTES AND EXPERIENCING A "DIABETIC ATTACK" WITH SUBSEQUENT LOSS OF CONSCIOUSNESS AND FALLING ON PAVEMENT ON HIS FACE AND ELBOW. THE CUSTOMER SELF-PRESENTED AT ER WHERE HE WAS TREATED FOR "CRACKED RIBS AND KNEE DAMAGE" AND TAKEN OFF GLIPIZIDE. THE CUSTOMER ALSO REPORTEDLY SELF-TREATED WITH FOOD TO COUNTERACT THE EVENT. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT, HOWEVER, THE READING OF 20 MG/DL WAS INDICATIVE OF HYPOGLYCEMIA AND CONSISTENT WITH LOSS OF CONSCIOUSNESS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A488

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R