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

Model Number	IMMULITE 2000 XPI
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered out of range on the day of the event.A siemens customer service engineer (cse) adjusted the reagent dual resolution dilutor (drd), checked substrate dispensing, and cleaned the sample probe with naoh.After the procedure, the allergen specific ige calibration was adequate, however, the qc precision was still not satisfactory, requiring the replacement of the reagent probe.After this action, qc recovered in range.The cause of the event was a mechanical issue which was resolved by routine troubleshooting.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely low allergen specific ige results were obtained on multiple patient samples on an immulite 2000 xpi system.The erroneous results were reported to the physician(s).Depending on the sample, the sample was rerun for allergen specific ige on an alternate system either one, two, or three days after the initial sample was run, and the results recovered higher.One of the samples was run again for allergen specific ige three days later on a second alternate system, confirming the higher results.A corrected report was only issued for the sample which had been repeated twice, in which case the higher 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 low allergen specific ige results.

• Brand Name: IMMULITE 2000 XPI
• Common Device Name: IMMULITE 2000 XPI
• 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: 19795211
• Report Number: 2247117-2024-00011
• Device Sequence Number: 17955048
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: (01)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): 07/22/2024

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
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/22/2024
• 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