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	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Three falsely depressed activated partial thromboplastin time (aptt) results were obtained using pathromtin sl reagent on a patient sample on two sysmex cs-5100 systems.When the sample was initially processed on one of the sysmex cs-5100 systems, the initial aptt result obtained on sysmex cs-5100 system (serial number: (b)(6)) recovered higher.The initial 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 falsely low aptt results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Siemens is investigating the issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2023-00013 on 06-sep-2023.Additional information (08-sep-2023): siemens further evaluated the incident and determined that there was no reagent issue.Quality controls (qc) recovered in range at the time of the event.A repeatability and comparison study was performed between both sysmex cs-5100 systems for activated partial thromboplastin time (aptt) and the aptt results were comparable on both systems.No further erroneous results have been reported.Preanalytical variables potentially contributed to this event.The investigation findings and investigation conclusion codes in section h6 were updated to reflect the additional information.The reagent is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2023-00014 and 9610806-2023-00015 and the associated supplemental reports were also filed for this event.

• 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
• 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: 17695203
• Report Number: 9610806-2023-00013
• Device Sequence Number: 6246969
• Product Code: GFO
• UDI-Device Identifier: 00842768007538
• UDI-Public: 00842768007538
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 09/18/2024
• Device Model Number: PATHROMTIN SL
• Device Catalogue Number: 10446067
• Device Lot Number: 536751A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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