MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number	DADE INNOVIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.Quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.No other samples were impacted.The customer checked the sample for clots and remixed the sample before rerunning it at 13:58 h, which resolved the issue.The cause of the event is a pre-analytical issue, likely due to improper mixing of the sample tube.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The discordant results were flagged with an "analysis time over" error and were not reported to the physician(s).The sample was repeated for pt and inr, both of which again recovered falsely elevated.These results were not flagged and were reported to the physician(s), who questioned the results.The sample was then remeasured for pt and inr, both of which recovered lower.The lower pt and inr 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 discordant, falsely elevated pt and inr results.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 12639468
• Report Number: 9610806-2021-00065
• Device Sequence Number: 14538994
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: 00630414023472
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 02/25/2023
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873566
• Device Lot Number: 549771D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1