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

Model Number PATHROMTIN SL

Device Problem Low Test Results (2458)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.Quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.The sample status of the affected sample displayed as "sample tube underfilled" on the system.Preanalytical factors cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The atellica coag 360 system is not marketed in the us nor similar in design to a siemens product registered in the us.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely low activated partial thromboplastin time (aptt) result was obtained on a patient sample on an atellica coag 360 system using pathromtin sl reagent.The discordant result was not reported to the physician(s).The sample was repeated for aptt, recovering higher.The higher aptt result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt result.

• Brand Name: PATHROMTIN SL
• Type of Device: PATHROMTIN SL
• 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: 12639459
• MDR Text Key: 277399009
• Report Number: 9610806-2021-00066
• Device Sequence Number: 1
• Product Code: GFO
• UDI-Device Identifier: 00842768007521
• UDI-Public: 00842768007521
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: PATHROMTIN SL
• Device Catalogue Number: 10446066
• Device Lot Number: 536730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/15/2021
• 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
• Patient Age: 49 YR