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

Model Number	IMMULITE 2000 XPI SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The calibration in use at the time of processing was evaluated and was found to be adequate according to the equipment's history.Quality controls (qc) recovered low for level 1 at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.Verification of alignments and functionality tests were carried out during the cse visit.The system was operational upon completion of the cse visit.A mechanical issue cannot be ruled out as a potential cause of the event.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Erroneous, falsely low insulin-like growth factor-1 (igf-1) results were obtained on two patient samples on an immulite 2000 xpi system (serial number: (b)(6).The falsely low results were not reported to the physician(s).When repeated, the samples recovered higher for igf-1.The higher results were considered correct and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low igf-1 results.

• 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: 18247020
• Report Number: 2247117-2023-00010
• Device Sequence Number: 20597913
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: 00630414945422
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2023

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
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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