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	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).A quality control (qc) failure was observed at the time of the event.The immulite 2000 xpi system presented clot detection errors on (b)(6) -2024 and on 03-apr-2024.The system had undergone service intervention on (b)(6) 2024 due to an error when pipetting reagent.The customer service engineer (cse) aligned the reagent arm in relation to the carousel, the dispensing angle was checked, and the probe was cleaned.Siemens is investigating the issue.
Event or Problem Description
The customer contacted siemens and reported that erroneous, falsely low insulin-like growth factor-1 (igf-1) results were obtained on an immulite 2000 xpi system (s/n: o6230).The samples were repeated for igf-1 on an alternate immulite 2000 xpi system.The repeat results were considered to be the correct results and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous igf-1 results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2247117-2024-00006 on 09-may-2024.Additional information (17-jun-2024): the siemens customer service engineer (cse) aligned the reagent arm in relation to the carousel, checked the dispensing angle, and externally cleaned the probe.An instrument issue therefore cannot be ruled out as a potential cause of the event.Quality controls (qc) and results are now recovering acceptably on the instrument.The customer is operational.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Supplemental mdr 2247117-2024-00007 was also filed for this additional information.

• 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: 19279827
• Report Number: 2247117-2024-00006
• Device Sequence Number: 6358919
• 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,Followup
• Report Date (Section B): 07/12/2024

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: 04/16/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/12/2024
• 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