MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY; ADVIA CHEMISTRY TOB_2 REAGENTS (4 X 100 TESTS)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated tobramycin_2 (tob_2) result on a neonatal patient sample on an advia chemistry xpt system.The erroneously elevated result was reported to the physician(s), and the result was questioned.The same sample was reprocessed on the original advia chemistry xpt system.Also, a new sample was drawn from the same patient and processed on the original advia chemistry xpt system.Lower results were obtained, considered correct, and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tobramycin_2 (tob_2) result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding an erroneously elevated tobramycin_2 (tob_2) result on a neonatal patient sample obtained on an advia chemistry xpt system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (29-may-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.The instrument data showed that the calibration was acceptable and quality control (qc) recovery was within the customer¿s expected ranges.The customer performed a qc precision study, and the results obtained were within the customer¿s expected ranges.The tobramycin_2 (tob_2) assay and the advia chemistry xpt system were performing acceptably, and the issue was resolved by reprocessing the same sample.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00068 was filed on 17-apr-2024.

• Brand Name: ADVIA CHEMISTRY
• Common Device Name: ADVIA CHEMISTRY TOB_2 REAGENTS (4 X 100 TESTS)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19125037
• Report Number: 2432235-2024-00068
• Device Sequence Number: 18052702
• Product Code: KLB
• UDI-Device Identifier: 00630414561677
• UDI-Public: 00630414561677
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K003341
• 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): 06/05/2024

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 10376932
• Device Lot Number: 170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Unknown