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	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Following the observation of out-of-range quality control (qc) results with the igf-i assay on an immulite 2000 xpi instrument, previously tested patient samples were reviewed.Falsely depressed igf-i results were observed with 10 patient samples.The initial erroneous results were not reported to the physician(s).When the samples were repeated on an alternate immulite 2000 xpi instrument in the customer¿s lab, 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 igf-i results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report falsely depressed igf-i results that were obtained on patient samples on an immulite 2000 xpi instrument.Quality controls (qcs) recovered out of ranges on the day of the event, which prompted the repeat testing of the patient samples.Historical qc results since (b)(6) 2023 were reviewed, and it was noted that inaccurate qc had been observed prior to the event.A reagent probe was changed and the instrument underwent preventative maintenance on 30-oct-2023.Afterwards, a qc precision study and a sample comparability study were performed and the results were acceptable and the assay was approved for sample processing.The customer is now operational.Hardware problems, resolved by the preventative maintenance, are the suspected root cause of the qc inaccuracy and falsely depressed patient results.Siemens views the preventative maintenance performed on 30-oct-2023 to be what resolved the initial issue.In this case, preventative maintenance was performed as a routine troubleshooting measure to try and resolve the issue and it was successful.No further investigation is needed.No product issue identified.

• Brand Name: IMMULITE 2000 XPI
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 62 flanders barley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 2247117; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: karen confort ; 333 coney st; e. walpole, MA 02032 ; 3392069063
• MDR Report Key: 18246664
• Report Number: 2247117-2023-00008
• Device Sequence Number: 15114467
• 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): Y
• 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: N/A
• Device Catalogue Number: 10373214
• 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
• 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