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

Model Number PATHROMTIN SL

Device Problem High Test Results (2457)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

Falsely elevated activated partial thromboplastin time (aptt) results were obtained on a patient sample using pathromtin sl reagent on two sysmex cs-5100 systems.The first erroneous result was reported and questioned by the physician(s) as the patient previously had a lower aptt result two days prior.The sample was then repeated for aptt on a non-siemens analyzer using a non-siemens reagent, recovering lower.The lower 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 elevated aptt results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2023-00014 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 9610806-2023-00013 and 9610806-2023-00015 and the associated supplemental reports were also filed for this event.

• 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: 17695213
• MDR Text Key: 322812009
• Report Number: 9610806-2023-00014
• Device Sequence Number: 1
• Product Code: GFO
• UDI-Device Identifier: 00842768007538
• UDI-Public: 00842768007538
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K955450
• 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,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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