BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 INTACT PTH

    MDR report key: 1671805 · Received March 30, 2010

    Report

    Report Number
    2017183-2010-00015
    Event Type
    Other
    Date Received
    March 30, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 19, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CEW
    PMA / PMN Number
    K013566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM DATA INDICATES THAT THERE ARE NO KNOWN IMMULITE 2000 SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULTS. THE DISCORDANT RESULTS CAN BE ATTRIBUTED TO A SUSPECT LOT (10067) OF AQUISEL SAMPLE COLLECTION TUBES USED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT # 252, EXPIRATION DATE: 07/31/2010; LOT # 254, EXPIRATION DATE: 09/30/2010.

    Description of Event or Problem · 1

    DISCORDANT LOW IMMULITE 2000 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER AND QUESTIONED WHEN COMPARED TO THE RESULTS OF THESE PATIENTS RUN PREVIOUSLY. THE CUSTOMER IS CERTAIN THAT THE CAUSE OF THE DISCORDANT LOW IPTH RESULTS CAN BE ATTRIBUTED TO A SUSPECTED LOT OF THEIR AQUISEL SAMPLE COLLECTION TUBES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 2

    ANALYSIS OF THE SYSTEM DATA INDICATES THAT THERE ARE NO KNOWN IMMULITE 2000 SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULTS. THE DISCORDANT RESULTS CAN BE ATTRIBUTED TO A SUSPECT LOT (10067) OF AQUISEL SAMPLE COLLECTION TUBES USED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT # 252, EXPIRATION DATE: 07/31/2010; LOT # 254, EXPIRATION DATE: 09/30/2010.

    Description of Event or Problem · 2

    DISCORDANT LOW IMMULITE 2000 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER AND QUESTIONED WHEN COMPARED TO THE RESULTS OF THESE PATIENTS RUN PREVIOUSLY. THE CUSTOMER IS CERTAIN THAT THE CAUSE OF THE DISCORDANT LOW IPTH RESULTS CAN BE ATTRIBUTED TO A SUSPECTED LOT OF THEIR AQUISEL SAMPLE COLLECTION TUBES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 3

    ANALYSIS OF THE SYSTEM DATA INDICATES THAT THERE ARE NO KNOWN IMMULITE 2000 SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULTS. THE DISCORDANT RESULTS CAN BE ATTRIBUTED TO A SUSPECT LOT (10067) OF AQUISEL SAMPLE COLLECTION TUBES USED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT # 252, EXPIRATION DATE: 07/31/2010; LOT # 254, EXPIRATION DATE: 09/30/2010.

    Description of Event or Problem · 3

    DISCORDANT LOW IMMULITE 2000 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER AND QUESTIONED WHEN COMPARED TO THE RESULTS OF THESE PATIENTS RUN PREVIOUSLY. THE CUSTOMER IS CERTAIN THAT THE CAUSE OF THE DISCORDANT LOW IPTH RESULTS CAN BE ATTRIBUTED TO A SUSPECTED LOT OF THEIR AQUISEL SAMPLE COLLECTION TUBES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 4

    ANALYSIS OF THE SYSTEM DATA INDICATES THAT THERE ARE NO KNOWN IMMULITE 2000 SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULTS. THE DISCORDANT RESULTS CAN BE ATTRIBUTED TO A SUSPECT LOT (10067) OF AQUISEL SAMPLE COLLECTION TUBES USED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT # 252, EXPIRATION DATE: 07/31/2010; LOT # 254, EXPIRATION DATE: 09/30/2010.

    Description of Event or Problem · 4

    DISCORDANT LOW IMMULITE 2000 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER AND QUESTIONED WHEN COMPARED TO THE RESULTS OF THESE PATIENTS RUN PREVIOUSLY. THE CUSTOMER IS CERTAIN THAT THE CAUSE OF THE DISCORDANT LOW IPTH RESULTS CAN BE ATTRIBUTED TO A SUSPECTED LOT OF THEIR AQUISEL SAMPLE COLLECTION TUBES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 5

    ANALYSIS OF THE SYSTEM DATA INDICATES THAT THERE ARE NO KNOWN IMMULITE 2000 SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULTS. THE DISCORDANT RESULTS CAN BE ATTRIBUTED TO A SUSPECT LOT (10067) OF AQUISEL SAMPLE COLLECTION TUBES USED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT # 252, EXPIRATION DATE: 07/31/2010; LOT # 254, EXPIRATION DATE: 09/30/2010.

    Description of Event or Problem · 5

    DISCORDANT LOW IMMULITE 2000 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER AND QUESTIONED WHEN COMPARED TO THE RESULTS OF THESE PATIENTS RUN PREVIOUSLY. THE CUSTOMER IS CERTAIN THAT THE CAUSE OF THE DISCORDANT LOW IPTH RESULTS CAN BE ATTRIBUTED TO A SUSPECTED LOT OF THEIR AQUISEL SAMPLE COLLECTION TUBES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 6

    ANALYSIS OF THE SYSTEM DATA INDICATES THAT THERE ARE NO KNOWN IMMULITE 2000 SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULTS. THE DISCORDANT RESULTS CAN BE ATTRIBUTED TO A SUSPECT LOT (10067) OF AQUISEL SAMPLE COLLECTION TUBES USED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT # 252, EXPIRATION DATE: 07/31/2010; LOT # 254, EXPIRATION DATE: 09/30/2010.

    Description of Event or Problem · 6

    DISCORDANT LOW IMMULITE 2000 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER AND QUESTIONED WHEN COMPARED TO THE RESULTS OF THESE PATIENTS RUN PREVIOUSLY. THE CUSTOMER IS CERTAIN THAT THE CAUSE OF THE DISCORDANT LOW IPTH RESULTS CAN BE ATTRIBUTED TO A SUSPECTED LOT OF THEIR AQUISEL SAMPLE COLLECTION TUBES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Additional Manufacturer Narrative · 7

    ANALYSIS OF THE SYSTEM DATA INDICATES THAT THERE ARE NO KNOWN IMMULITE 2000 SYSTEM ISSUES WHICH COULD HAVE CONTRIBUTED TO THE DISCORDANT LOW IMMULITE 2000 IPTH TEST RESULTS. THE DISCORDANT RESULTS CAN BE ATTRIBUTED TO A SUSPECT LOT (10067) OF AQUISEL SAMPLE COLLECTION TUBES USED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. ADDITIONAL LOT # 252, EXPIRATION DATE: 07/31/2010; LOT # 254, EXPIRATION DATE: 09/30/2010.

    Description of Event or Problem · 7

    DISCORDANT LOW IMMULITE 2000 IPTH ASSAY RESULTS WERE OBTAINED BY THE CUSTOMER AND QUESTIONED WHEN COMPARED TO THE RESULTS OF THESE PATIENTS RUN PREVIOUSLY. THE CUSTOMER IS CERTAIN THAT THE CAUSE OF THE DISCORDANT LOW IPTH RESULTS CAN BE ATTRIBUTED TO A SUSPECTED LOT OF THEIR AQUISEL SAMPLE COLLECTION TUBES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW DISCORDANT IPTH ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 INTACT PTH INTACT PTH IMMUNOASSAY CEW SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 251

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3
    4
    5
    6
    7