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

Model Number	PATHROMTIN SL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PATHROMTIN SL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 12639459
• Report Number: 9610806-2021-00066
• Device Sequence Number: 4343987
• Product Code: GFO
• UDI-Device Identifier: 00842768007521
• UDI-Public: 00842768007521
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K955450
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR