MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000 XPI SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Falsely depressed insulin-like growth factor binding protein 3 (igfb-3) results were obtained on multiple patient samples on an immulite 2000 xpi instrument.The erroneous results were not reported to the physician(s).The samples were repeated on an alternate immulite 2000 xpi instrument.The repeat results were higher than the erroneous results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed insulin-like growth factor binding protein 3 (igfb-3) results.
Additional Manufacturer Narrative
An outside the us customer contacted a siemens customer care center to report falsely depressed insulin-like growth factor binding protein 3 (igfb-3) results on multiple patient samples on an immulite 2000 xpi instrument.Siemens is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2247117-2024-00002 on 22-march-2024.Additional information 21-june-2024: siemens evaluated this issue and provided the following conclusion: the customer performed a 10-patient comparison study on the complaint analyzer and an alternate immulite 2000 xpi.The data was analyzed and showed valid adjustments and quality control recovering within acceptable ranges.In addition, all patient samples recovered within 10% instrument-to-instrument.The customer is operational.The immulite 2000 xpi insulin-like growth factor binding protein 3 (igfbp-3) assay, lot 431, and the immulite 2000 xpi system are performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 XPI SYSTEM
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• 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: jennifer cacace ; 333 coney street; east walpole, MA 02032 ; 8024302902
• MDR Report Key: 18958072
• Report Number: 2247117-2024-00002
• Device Sequence Number: 14577954
• 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): 06/27/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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