BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-G

    MDR report key: 3071553 · Received April 22, 2013

    Report

    Report Number
    3002809144-2013-00115
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    May 14, 2012
    Report Date
    April 1, 2013
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION TEAM RECEIVED THE CUSTOMER RETURNED SPECIMENS BUT UNFORTUNATELY NO FURTHER INVESTIGATION COULD BE PERFORMED AS THE SAMPLE VOLUME OF THE 8 SAMPLES RECEIVED WAS NOT SUFFICIENT FOR PERFORMING ANY FURTHER TESTS. AS PART OF THIS EVALUATION, THE INVESTIGATION TEAM REVIEWED THE COMPLAINT RECORDS FOR THE AFFECTED LOT NUMBERS AND DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER OBSERVATION. A REVIEW OF THE HUMAN NEGATIVE POPULATION TESTING FOR FINAL RELEASE REVEALED NO INDICATIONS THAT THE SPECIFICITY OF THE LOT NUMBERS MIGHT BE ADVERSELY AFFECTED. AS PART OF THIS EVALUATION A REVIEW OF COMPLAINT RECORDS FOR THE AFFECTED LOT NUMBERS DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS ADEQUATELY ADDRESSED. IT HAS BEEN DETERMINED THAT THE ARCHITECT HAVAB IGG REAGENTS IDENTIFIED IN THIS EVENT WERE PERFORMING ACCEPTABLY AT THE TIME THE CUSTOMER OBSERVED THESE (B)(6) RESULTS AS ALL LOTS WERE STILL WITHIN THE REVISED EXPIRATION DATING OF 6 MONTHS. NO DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT HAVAB-IGG, LIST 6C29, THAT HAS A SIMILAR U.S. PRODUCT DISTRIBUTED IN THE U.S., ARCHITECT HAVAB-G, LIST 6L27. (B)(4). AN EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED (B)(6) ARCHITECT HAVAB-IGG RESULTS ON A PATIENT SERUM SAMPLE DURING LOOK BACK TESTING. ADDITIONAL TESTING SHOWED 6 OF THE 8 SAMPLES USED IN LOOK BACK TESTING HAD ARCHITECT HAVAB-IGM (B)(6) RESULTS. NO ADDITIONAL SPECIFIC PATIENT DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA PROVIDED: SAMPLE ID: (B)(6) , MALE, COLLECTION DATE OF (B)(6) 2012. ARCHITECT HAVAB-IGG = (B)(6) WITH LOT 15229LI00. VIDAS = (B)(6) (NO UNIT OF MEASURE PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172887 ARCHITECT HAVAB-G LOL ABBOTT GERMANY 15229LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL (B)(4)| SERIAL (B)(4)| ARCHITECT I2000SR, LIST 03M74-01| ARCHITECT I2000SR, LIST 03M74-01