MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT; TEST, TIME, PARTIAL THROMBOPLASTIN

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the observation of a falsely elevated activated partial thromboplastin time (aptt) result measured with the dade® actin® fsl activated ptt reagent on a sysmex cs-2500 system.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on the same instrument.The repeat result was lower than the erroneous result.The repeat 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 activated partial thromboplastin time (aptt) result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report a falsely elevated activated partial thromboplastin time (aptt) result measured with the dade® actin® fsl activated ptt reagent on a sysmex cs-2500 system.Quality controls (qcs) recovered within ranges on the day of the event in the morning and then qc failures were observed in the afternoon.Significant bubbles were noted in the reagent onboard.Aptt reagents were replaced and probes were cleaned.Qc was repeated following the troubleshooting and was in range.Patient samples that had been run during the day were repeated.Per the limitations section of the dade® actin® fsl activated ptt reagent instructions for use (ifu): "results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings." siemens is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2024-00024 on 13-aug-2024.Additional information 24-sep-2024: the following conclusion was made from the troubleshooting activities performed by siemens: issue resolution provided by use of standard troubleshooting and the customer is operational.Based on the available information, a reagent related issue can be excluded.The cause of the discordant activated partial thromboplastin time (aptt) result cannot be determined by siemens, and therefore further evaluation was requested by the product owner sysmex.Sysmex investigated the issue and determined that this issue was more likely a result of user's handling of the dade action fsl activated ptt reagent than a device malfunction.No other issues have occurred in the measurement of tests other than aptt, and this issue has not reoccurred since (b)(6) 2024.Therefore, it is considered unlikely that this issue is a device malfunction.When this issue occurred, significant bubbles were noted in reagent containers onboard.This suggests that there has been some problem in the user's handling of the aptt reagent, such as mixing cleaning water, calcium chloride (cacl2) solution, with the aptt reagent after qc was performed.The dilution of the aptt reagent or the inhalation of air bubbles when aspirating the reagent are expected to prolong the aptt clotting time.Based on the above, since this issue is suspected to be a single event caused by the user's handling of the aptt reagent, and since this issue has not reoccurred to date, sysmex has judged that further investigation is unnecessary.Overall conclusion: sysmex concluded that this issue was most likely caused by the user's handling of the aptt reagent.There are no indications of potential performance issues, neither with reagent nor with the instrument.No unacceptable risk has been associated with this event.No product problem could be identified.The sysmex cs-2500 system and the dade actin fsl activated ptt reagent lot 562721 are performing as intended.A product performance issue has not been identified.No further evaluation of the devices is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Common Device Name: TEST, TIME, PARTIAL THROMBOPLASTIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 19974110
• Report Number: 9610806-2024-00024
• Device Sequence Number: 7075206
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: (01)00842768003882(10)562721(17)240817
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K863594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 10/22/2024

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: 08/17/2024
• Device Model Number: N/A
• Device Catalogue Number: 10445714
• Device Lot Number: 562721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/22/2024
• Date Device Manufactured: 08/18/2022
• 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