MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE ANTITHROMBIN

Model Number	INNOVANCE ANTITHROMBIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely low antithrombin (at) result was obtained on a patient sample on a sysmex cs-2500 system using innovance antithrombin reagent.The discordant result was reported to the physician(s) and was questioned.The sample was rerun for at at an alternate laboratory, recovering higher.The higher 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 at result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2022-00007 on 18-feb-2022.Additional information (21-feb-2022): the results were evaluted correctly by the sysmex cs-2500 system software.Quality controls (qc) recovered in range and the issue was limited to one patient sample.Compared to the non-siemens assay used at the alternate laboratory, the innovance antithrombin assay uses an incubation time to facilitate an increased sensitivity to heparin binding site mutations.Sample specific interferences cannot be ruled out as a potential cause of the result discrepancy.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: INNOVANCE ANTITHROMBIN
• Common Device Name: INNOVANCE ANTITHROMBIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg
• 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: 13560336
• Report Number: 9610806-2022-00007
• Device Sequence Number: 11876387
• Product Code: JBQ
• UDI-Device Identifier: 00842768037146
• UDI-Public: 00842768037146
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081769
• 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): 03/17/2022

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: 08/05/2022
• Device Model Number: INNOVANCE ANTITHROMBIN
• Device Catalogue Number: 10709521
• Device Lot Number: 00406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female