MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000; IMMUNOASSAY ANALYZER

Model Number IMMULITE 2000

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

A discordant low prostate specific antigen (psa) result was obtained on one patient sample on an immulite 2000 instrument.It was unknown if the discordant psa result was reported to the physician.The sample was repeated three times on an alternate instrument, that were dilutions and resulted higher.The third repeated psa result was reported to the physician.There are no reports of patient intervention or adverse health consequences due to the discordant psa result.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse analyzed the instrument and instrument data and performed a water test, checked the sample and reagent probe alignment, probe dispense, tubing and valves.The cse also checked the wash spinner calibration and the substrate and water dispense.The cause of the discordant psa result was unknown.The cse successfully ran a precision test and qc.The system is performing within specifications.Further evaluation of the device is not required.

• Brand Name: IMMULITE 2000
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders; NJ 07836
• Manufacturer Contact: john nelson ; siemens healthcare diagnostics; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3667918
• MDR Text Key: 15267596
• Report Number: 2247117-2014-00012
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Device Catalogue Number: 30002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1