MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH TEST THROMBIN REAGENT

Model Number TEST THROMBIN REAGENT

Device Problem High Test Results (2457)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range for both lots of test thrombin reagent on the day of the event.Siemens evaluated qc using both lot 01552 and lot 02056 of test thrombin reagent.All measured qc values recovered within the assigned ranges, independent of the reagent lot used.Siemens also measured five fresh frozen plasma samples and five heparinized plasma samples using both lot 01552 and lot 02056 of test thrombin reagent.A low result bias was observed with lot 01552 compared to lot 02056; however, no product problem was identified.Lot 02056 demonstrates an improved sensitivity for heparin.

Event Description

The customer reported that higher thrombin time (tt) results were obtained on five patient samples on a sysmex cs-5100 system using test thrombin reagent lot 02056, compared to the recoveries from an alternate sysmex cs-5100 system using test thrombin reagent lot 01552.The customer indicated that the lower tt results were considered correct and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the different tt results.

• Brand Name: TEST THROMBIN REAGENT
• Type of Device: TEST THROMBIN REAGENT
• 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: 17996820
• MDR Text Key: 327625178
• Report Number: 9610806-2023-00019
• Device Sequence Number: 1
• Product Code: GJA
• UDI-Device Identifier: 00842768012716
• UDI-Public: 00842768012716
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/24/2023

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
• Device Operator: Health Professional
• Device Model Number: TEST THROMBIN REAGENT
• Device Catalogue Number: 10446598
• Device Lot Number: 02056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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