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

Model Number	ADVIA CHEMISTRY XPT
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) distributor informed siemens that a falsely depressed creatine kinase (ck_l) result was reportedly obtained on a patient sample on an advia chemistry xpt instrument.Quality control (qc) was valid at the time of sample processing.The customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and observed a loose connection on the dilution probe circuit board.The dilution probe circuit board was determined to be incorrectly connected to the dilution probe, which caused incorrect aspiration of the patient sample.The cse corrected the circuit board connections, which returned the instrument to normal operations.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The distributor informed siemens that a falsely depressed creatine kinase (ck_l) result was reportedly obtained on a patient sample on an advia chemistry xpt instrument.The erroneous result was not reported to the physician(s).The sample was repeated on an alternate advia chemistry 1800 instrument and on the same instrument.The repeat results recovered higher than the erroneous result, matched patient¿s condition and were considered correct.The repeat result from an alternate advia chemistry 1800 instrument was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ck_l result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00096 on 14-may-2024.Additional information (20-may-2024): upon reviewing the instrument files, siemens identified that the sample was repeated 2 additional times on the same instrument, and the sample recovered without a result.Instead, absorbance limit(u) errors were produced.Siemens further evaluated the event and concluded that the loose connection on the dilution probe circuit board (dilution pipetting probe (dpp) level sense board), addressed with the service actions mentioned in the initial report, potentially contributed to the falsely depressed creatine kinase (ck_l) result.Section b6 and the investigation conclusion code in section h6 were updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CHEMISTRY XPT
• Common Device Name: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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: 19311983
• Report Number: 2432235-2024-00096
• Device Sequence Number: 15189154
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 00630414595467
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• PMA/510(K) Number: K990346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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
• Device Catalogue Number: 10723034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/05/2024
• 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 Age: 7 YR
• Patient Sex: Male