MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® TACROLIMUS FLEX® REAGENT CARTRIDGE

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	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding five (5) falsely elevated tacrolimus (tac) patient results obtained on a dimension® exl¿ 200 system.Siemens is investigating the event.
Event or Problem Description
Five (5) discordant falsely elevated tacrolimus (tac) patient results were obtained on a dimension® exl¿ 200 system.The falsely elevated results were reported to the physician and the results were questioned.The same samples were reprocessed on the original instrument.Lower results obtained were considered correct.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
Additional information (02-apr-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.Calibration and quality control (qc) recovered within customer's acceptable ranges.The customer repeated the samples on the same system and obtained the expected results, no discrepancies were observed with other patient results.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Sections h6 have been updated to reflect the hsc investigation.Initial mdr 2517506-2024-00010 was filed on 08-jan-2024.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TACROLIMUS FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18465807
• Report Number: 2517506-2024-00010
• Device Sequence Number: 7192106
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: 00842768035425
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 08/13/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 10700795
• Device Lot Number: GA4226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown