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

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

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 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.

• Brand Name: DIMENSION®
• Type of Device: 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
• MDR Text Key: 335949892
• Report Number: 2517506-2024-00073
• Device Sequence Number: 1
• Product Code: MLM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/25/2024
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1