BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IPTH

    MDR report key: 2073489 · Received May 1, 2011

    Report

    Report Number
    1415939-2011-00141
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TESTING WAS PERFORMED USING AN IN-HOUSE FILE KIT OF ARCHITECT IPTH REAGENT 8K25 LOT 02110G00. TESTING WAS COMPLETED USING BOTH THE ROUTINE MODE AND THE STAT MODE FOR A TOTAL OF 6 RUNS. FOR EACH TESTING SCHEME, THREE ARCHITECT INSTRUMENTS WERE CALIBRATED, AND A SINGLE REPLICATE OF ARCHITECT INTACT PTH CONTROLS WERE TESTED. USING THE ACCEPTED CALIBRATION CURVE TEN REPLICATES OF EACH LEVEL OF THE ARCHITECT INTACT PTH CONTROLS WERE RUN. THE INDIVIDUAL REPLICATES AND THE GRAND MEAN WERE EVALUATED AGAINST THE CONTROL ACCEPTANCE CRITERIA, ALL INDIVIDUAL REPLICATES AND GRAND MEANS WERE WITHIN ACCEPTANCE CRITERIA FOR EACH LEVEL. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, (B)(4).

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT DISCREPANT ARCHITECT IPTH RESULTS WERE GENERATED ON A DIALYSIS PATIENT SAMPLE. AN INITIAL RESULT OF 4.0 PG/ML WAS GENERATED. THE SAMPLE WAS REPEATED WITH RESULTS OF 161 AND 150 PG/ML. THE SAMPLE WAS RUN AGAIN THE FOLLOWING DAY AND A RESULT OF 0.00 PG/ML WAS GENERATED. ANOTHER SAMPLE FROM THE SAME PATIENT GAVE AN INITIAL RESULT OF 5.9 PG/ML WITH REPEAT RESULTS OF 251 AND 235 PG/ML. THIS SAMPLE WAS ALSO REPEATED THE FOLLOWING DAY WITH A RESULT OF 0.00 PG/ML GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IPTH FOR THE DETERMINATION OF INTACT PARATHYROID HORMONE IN SERUM OR PLASMA CEW ABBOTT LABORATORIES 02110G00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 ANALYZER 3M74-01 (B)(4)| ARCHITECT I2000 ANALYZER 3M74-01 (B)(4)