MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI SYSTEM

Model Number	IMMULITE 2000 XPI SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.No error conditions were observed.During troubleshooting, the customer realized that there was no water being dispensed from the water probe.A siemens customer service engineer was dispatched to the customer's site.The issue was resolved with the service visit.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Erroneous, falsely elevated free prostate specific antigen (fpsa) and total prostate specific antigen (psa) results were obtained on multiple patient samples on an immulite 2000 xpi system.The falsely elevated results were not reported to the physician(s).The customer repeated the samples that had recovered falsely elevated and reported the repeat results, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2247117-2023-00011 on 04-dec-2023.Additional information (01-feb-2024): the siemens customer service engineer (cse) replaced the water pump assembly and verified the pump performance, after which quality controls (qc) recovered acceptably.The customer is fully operational after replacement of the water pump.The investigation conclusions code in section h6 was updated based on the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: IMMULITE 2000 XPI SYSTEM
• Common Device Name: IMMULITE 2000 XPI SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 2247117; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 18259055
• Report Number: 2247117-2023-00011
• Device Sequence Number: 7891016
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: 00630414945422
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K970227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMMULITE 2000 XPI SYSTEM
• Device Catalogue Number: 10373214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown