MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY TOBRAMYCIN_2 (TOB_2)

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	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a falsely elevated tobramycin_2 (tob_2) result on an advia® chemistry xpt system.Siemens is investigating the event.
Event or Problem Description
A falsely elevated tobramycin_2 (tob_2) patient sample result was obtained upon repeat on an advia® chemistry xpt system.The repeat result was not reported to the physician(s) the initial, lower result was considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tobramycin_2 (tob_2) result.
Additional Manufacturer Narrative
Additional information (24-may-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available data logs.The customer performed a quality control study and when the sample volume was increased the results of the study were acceptable.The neonatal patient sample was a very small amount, and the cause of the event is consistent with low sample volume.A potential product issue was not identified.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 2432235-2024-00066 was filed on 15-april-2024.

• Brand Name: ADVIA CHEMISTRY TOBRAMYCIN_2 (TOB_2)
• Common Device Name: TOBRAMYCIN_2 (TOB_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; registration #2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19110264
• Report Number: 2432235-2024-00066
• Device Sequence Number: 7628952
• Product Code: LCR
• 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: 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 04/15/2024
• 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: 5 DA
• Patient Sex: Unknown