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

Model Number INNOVANCE ANTITHROMBIN, HIGH VOLUME

Device Problem High Test Results (2457)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).In the system backup files that were provided, no general system issue could be found.Quality controls (qc) recovered in range at the time of the event.No issues were observed with the reaction kinetics.The repetitions were performed out of different sample tubes than the initial result.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.The innovance antithrombin, high volume reagent is marketed in the united states under material number 10487303.The 510(k) number documented in section g4 is for this product.

Event Description

An erroneous, falsely elevated antithrombin (at) result was obtained on a patient sample on a sysmex cn-3000 system using innovance antithrombin, high volume reagent.The erroneous result was reported to the physician(s).A sample from the same sample archive rack was repeated for at and the at result recovered lower.Another sample from the same sample archive rack was repeated for at and the at result matched the lower result.Three days later, a new sample from the patient was collected and was run for at, again matching the lower results.The lower results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated at result.

• Brand Name: INNOVANCE ANTITHROMBIN, HIGH VOLUME
• Type of Device: INNOVANCE ANTITHROMBIN, HIGH VOLUME
• 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: 18336297
• MDR Text Key: 330611187
• Report Number: 9610806-2023-00022
• Device Sequence Number: 1
• Product Code: JBQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081769
• 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: 12/15/2023

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 Expiration Date: 03/06/2024
• Device Model Number: INNOVANCE ANTITHROMBIN, HIGH VOLUME
• Device Catalogue Number: 10446015
• Device Lot Number: 01696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male