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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the observation of falsely depressed veterinary patient results with phenobarbital (phen), lot 327 on an immulite® 2000 xpi immunoassay system.Quality control (qc) recovered within range when repeated.A siemens customer service engineer (cse) went on site and checked the system and found no leaks in the reagent probe, sample probe as well as their tubing.The alignments of the probes were checked and were good.The system was primed and no errors were observed.The probe dispense angles were good.The temperature of the system is within specification.The watertestpm was run and no issues were identified.The system was realigned and an iml.File error was observed.The cse cleaned the dual resolution diluter (drd) panel and alignment it.The water test was within specification.Additionally, both drd's were replaced and the filters were swapped.The alignments were checked and a decontamination was performed.The system calibrations and qc were run for the phen assay and passed.According to this information the instrument is fully functional.Siemens determine that the actions from service are part of routine troubleshooting and resolved the issue.The limitations section of the immulite 2000 phenobarbital instructions for use states: "for diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings.".
Event or Problem Description
The customer reported the observation of falsely depressed veterinary patient results with phenobarbital (phen), lot 327 on an immulite® 2000 xpi immunoassay system, serial number: (b)(6).The falsely depressed patient results were reported to the physicians and were questioned.The samples were reprocessed on the original instrument, or on the customer's alternate instrument and one sample was sent to an alternate lab, instrument is unknown.All reprocessed samples recovered higher.Corrected reports were issued.The customer indicated the issue started on (b)(6) 2024 and potentially there have been approximately 20 occurrences of discrepancies with veterinary patient samples, however.The customer provided results from three samples tested on (b)(6) 2024.The customer also stated the issue is occurring with quality control (qc).The qc for this assay would result as "" and then repeated with the same control material and would then be in range.There is no known reports of patient intervention or adverse health consequences due to the issue.

• Brand Name: IMMULITE 2000 XPI
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 62 flanders bartley road; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 20335836
• Report Number: 2247117-2024-00015
• Device Sequence Number: 8004269
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: (01)00630414945422
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 09/30/2024

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: N/A
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown