BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 2070106 · Received April 27, 2011

    Report

    Report Number
    3002809144-2011-00216
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ABBOTT
    Product Code
    LOL
    PMA / PMN Number
    K063329
    Removal / Correction Number
    3002809144-4/21/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):IN THE PREVIOUS SUBMISSION, THE TYPE OF REMEDIAL ACTION WAS SUBMITTED AS A PRODUCT CORRECTION. THE TYPE OF REMEDIAL ACTION TAKEN BY ABBOTT WAS A RECALL.

    Additional Manufacturer Narrative · 1

    INTERNAL IDENTIFIER(S): = (B)(4). CONCOMITANT MEDICAL DEVICE: ARCHITECT I1000SR ANALYZER, LIST # 1L86-01, SERIAL # (B)(4). EVALUATION RESULTS: CROSS CONTAMINATION WAS IDENTIFIED AS A POTENTIAL CAUSE. CONCLUSION: (B)(4) MANUFACTURING PROCESS. AN ADVERSE TREND IN US CUSTOMER COMPLAINTS FOR ARCHITECT HAVAB-IGM ASSAY (LIST NUMBER 6L21) REGARDING HIGHER THAN USUAL GRAYZONE/(B)(6) RESULTS RATE WAS DETECTED ON MARCH, 2009. THE INVESTIGATION REVEALED THE MOST PROBABLE CAUSE FOR THE INCREASE RATE OF (B)(6) RESULTS IS THE HAV ANTIGEN CODE 26286 WHICH HAS A REDUCED POTENCY THAT AFFECTS THE ARCHITECT HAVAB-IGM PERFORMANCE. (B)(4). AS A RESULT, THE SIGNAL TO NOISE RATIO IS SHIFTED SPECIALLY IN THE NEGATIVE SAMPLES LEAVING THE ASSAY PRONE FOR FALSE GRAYZONE/(B)(6) RESULTS AND INCREASES ARCH HAVAB-IGM ASSAY SUSCEPTIBILITY TO REAGENT CROSS CONTAMINATION AND TEST SYSTEM VARIABILITY. AS A PREVENTIVE MEASURE TO PROTECT THE INTEGRITY OF TEST RESULTS, CUSTOMERS WERE INSTRUCTED BY A PRODUCT INFORMATION LETTER TO FOLLOW AN ALTERNATIVE PROCESSING METHOD BY SEGREGATING ALL HAVAB-IGM SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED HIGHER THAN NORMAL (B)(6)/GRAY ZONE ARCHITECT HAVAB-M PATIENT RESULTS WHEN REAGENT LOT 93794HN00 WAS IN USE AND STATED THAT HAVAB-M INITIAL (B)(6) RESULTS WERE HIGH FOR THEIR LAB. THE CUSTOMER OBSERVED FOUR GRAY ZONE RESULTS WITHIN THE PREVIOUS 2 WEEKS, AND UPON REPEAT TESTING, REMAINED IN THE GRAY ZONE. THESE GRAY ZONE RESULTS WERE REPORTED OUT OF THE LAB AS INDETERMINATE. THE CUSTOMER STATED THE HAVAB-M NEGATIVE CONTROL WAS RUNNING AS EXPECTED, ALTHOUGH SOME IMPRECISION WAS NOTED WITH THE POSITIVE CONTROL. THE CUSTOMER FURTHER STATED ALL OTHER ASSAYS WERE RUNNING AS EXPECTED. THE CUSTOMER WAS ADVISED TO PERFORM A PROBE CHANGE AND RECALIBRATION AND ADDITIONAL TROUBLESHOOTING MEASURES WITH FRESH HAVAB-M CALIBRATORS. THE CUSTOMER PROVIDED AN EXAMPLE OF THE HAVAB-M GRAY ZONE RESULT AS FOLLOWS: PATIENT #4 INITIAL RESULT IN TRIPLICATE: (B)(6). REPEAT RESULT IN DUPLICATE WITH A NEW SAMPLE: 1 (B)(6). THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HAVAB IGM REAGENT FOR THE DETECTION OF IGM ANTIBODIES TO HEPATITIS A VIRUS LOL ABBOTT 93794HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER, LIST # 1L86-01| ARCHITECT I1000SR ANALYZER, LIST # 1L86-01