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 Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).A customer service engineer (cse) was dispatched to the customer site.The cse verified that the alignments were within specifications and ran four precision runs which all passed.Quality controls (qc) recovered within range at the time of the event.There were no instrument errors at the time of the event.No other patient samples or assays were affected.Sample collection and handling errors with the original sample cannot be ruled out.It is unknown if the sample tube was sufficiently mixed 3-6 times immediately after blood collection or if there were any clots present in the sample tube.The cause of the discordant, falsely elevated prothrombin time (pt) result and the discordant, falsely elevated prothrombin time international normalized ratio (inr) result is unknown.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) result and a discordant, falsely elevated prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a sysmex cs-2500 system using dade innovin reagent.The discordant results were flagged with the error "upper report limit over".The discordant results were reported to the physician(s) and were questioned by the physician(s).The patient was redrawn and the new sample was run for pt and inr, both resulting lower.These pt and inr results were reported, as the correct results, to the physician(s).Three days later, both the initial and the redrawn samples were rerun for pt and inr on an alternate sysmex cs-2500 system.The results matched the pt and inr results previously obtained for the redrawn sample.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) result and the discordant, falsely elevated prothrombin time international normalized ratio (inr) result.

• 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: 9922656
• Report Number: 9610806-2020-00011
• Device Sequence Number: 3271827
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (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): 04/03/2020

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: 07/12/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR