MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT

Model Number	ADVIA CHEMISTRY XPT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center (ccc) and reported that erroneous results on multiple assays were obtained on a patient sample on an advia chemistry xpt instrument.The quality control (qc) was acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and found spillage and crystallization around the drains.The cse performed preventive maintenance on the instrument, cleaned dilution pipetting probe (dpp) and sample probe drains, and ran qc which recovered acceptably.The cse notified the customer to improve the instrument maintenance.The cause of the erroneous results is unknown.The instrument is performing according to specifications.No further evaluation of these devices is required.
Event or Problem Description
Erroneous enzymatic creatinine_2 (ecre_2), concentrated calcium_2 (ca_2c), and total bilirubin_2 (tbil_2) results were obtained on a patient sample on an advia chemistry xpt instrument.The erroneous results were reported to the physician(s).The sample was repeated on an alternate advia chemistry xpt instrument.The repeat results correlated with previous results for the patient.The repeat results were reported as the correct results to the physician(s).The customer did not provide the affected patient results to siemens.The mdr is being filed in abundance of caution.There are no known reports of patient intervention or adverse health consequences due to the erroneous results.
Additional Manufacturer Narrative
Siemens filed the initial mdr (b)(4) on 30-may-2023.(07-jun-2023): in addition to the service actions described in the initial report, the customer service engineer (cse) also performed the shutdown wash.Siemens further reviewed the instrument data and concluded that since the quality control (qc) recovery was within expected ranges before and after the sample was processed, there was no evidence of a reagent issue.Siemens concluded that improper alignment of probes and sample quality caused spillage and crystallization around the drains.The cse delineated the instrument¿s appearance to the laboratory's management to suggest improvement in maintenance and training.The investigation conclusions code was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of these devices is required.

• Brand Name: ADVIA CHEMISTRY XPT
• Common Device Name: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown, NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 17019489
• Report Number: 2432235-2023-00128
• Device Sequence Number: 7167972
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 00630414595467
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K990346
• 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): 06/23/2023

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: ADVIA CHEMISTRY XPT
• Device Catalogue Number: 10723034
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/23/2023
• 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