MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PATHROMTIN SL (RILIBAK)

Model Number SEE H10

Device Problem High Test Results (2457)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no instrument or application issue was identified.The pathromtin sl instructions for use (ifu) indicates "pathromtin sl must be gently inverted (5 to 8 times) to mix before first use".Sedimentation of the pathromtin sl reagent cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.The pathromtin sl (rilibak) reagent is not marketed in the united states (us).This mdr is filed for the us similar reagent (pathromtin sl reagent).The pathromtin sl reagent marketed in the us has catalog number: 10446066, unique device identifier (b)(4), and the pma/510(k) k955450.

Event Description

Two falsely elevated activated partial thromboplastin time (aptt) results were obtained on two patient samples on a sysmex cs-5100 system using pathromtim sl (rilibak) reagent.The discordant results were not reported to the physician(s).The sample from patient 1 was repeated for aptt using a new reagent vial on the same system, and the sample from patient 2 was repeated for aptt using an alternate sysmex cs-5100 system.The repeat aptt results for both patients recovered lower.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the elevated aptt results.

• Brand Name: PATHROMTIN SL (RILIBAK)
• Type of Device: PATHROMTIN SL (RILIBAK)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16095513
• MDR Text Key: 308534260
• Report Number: 9610806-2023-00001
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEE H10
• Device Catalogue Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1