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

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the erroneous tacrolimus results obtained on patient samples on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
Discordant tacrolimus (tac) results were obtained on multiple patient samples on a dimension exl 200 system.The erroneous results were not reported to the physician(s).The same samples were reprocessed on the original dimension exl 200 system.The reprocessed results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to reported event.
Additional Manufacturer Narrative
Additional information (15-july-2024): siemens concluded the investigation of the event.Siemens reviewed the available instrument data files and the information provided by the customer.Quality control (qc) recovered outside the customer's acceptable ranges.The customer used a new reagent tacrolimus (tac) lot (lot# ga4030), processed a passing calibration, and processed qc, which produced acceptable results.Based on the available information from the customer and the investigation, a product problem 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 siemens investigation.Initial mdr 2517506-2024-00073 was filed on 19-feb-2024.

• Brand Name: DIMENSION®
• Common Device Name: 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: 18729962
• Report Number: 2517506-2024-00073
• Device Sequence Number: 12810085
• Product Code: MLM
• UDI-Device Identifier: 00842768035425
• UDI-Public: 00842768035425
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: 02/14/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 10700795
• Device Lot Number: GA4045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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 Sex: Unknown