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

Model Number	ADVIA CHEMISTRY XPT SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that out-of-range quality controls and falsely depressed total bilirubin_2 (tbil_2) results were obtained on patient samples on an advia chemistry xpt system.The erroneous results were reported to the physician(s).The samples were repeated on an alternate system.The repeat results were higher than the erroneous results.The customer has not provided any further information related to this incident.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed tbil_2 results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report that falsely depressed total bilirubin_2 (tbil_2) results were obtained on patient samples on an advia chemistry xpt system.Quality controls (qcs) recovered out of ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse heard a tapping noise when the mixer paddle went into the dilution tray (dtt) cuvettes, suggesting the mixer paddle was low.The cse reviewed the dilution mixer (dmix) set up and determined the mix1 and mix 2 settings were low.The height was adjusted, and the assembly was leveled.Additionally, the cse repositioned the reagent dispensing pump 2 (rp2) probe and ran a 20-repetition precision check, which demonstrated good repeatability.The customer ran qcs, which recovered within ranges.The cause of the falsely depressed tbil_2 results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00176 on 09-aug-2024.Additional information (14-aug-2024): in addition to the service actions mentioned in the initial report, the customer service engineer (cse) centralized the mixer paddle movements.Siemens further evaluated the event and determined that mixer and probe alignments potentially contributed to the falsely depressed total bilirubin_2 (tbil_2) results.The investigation conclusions code of section h6 was updated to reflect the additional information.The analyzer is performing within specifications.No further evaluation of this analyzer is required.

• Brand Name: ADVIA CHEMISTRY XPT SYSTEM
• Common Device Name: ADVIA CHEMISTRY XPT SYSTEM
• 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: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 19955863
• Report Number: 2432235-2024-00176
• Device Sequence Number: 15667561
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: (01)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): 08/27/2024

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: ADVIA CHEMISTRY XPT SYSTEM
• Device Catalogue Number: 10723034
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/27/2024
• 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