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	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that discordant, falsely elevated prothrombin time (pt) and pt international normalized ratio (inr) results were obtained on a patient sample, using the dade innovin reagent, on a sysmex ca-1500 system.Quality controls (qcs) were within acceptable ranges prior to and after the discordant results were obtained.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse examined sample and qc recoveries since the discordant results were obtained, and found no issue.The cse: checked the power voltage; inspected the tubing to probes; tested the mixing, which the cse determined was within acceptable ranges; verified that the vessel contents were vortexing according to specifications; checked and set all alignments; ran qcs and calibrated clot detectors.The cse also checked and calibrated temperature controls as the incubation temperature was elevated.Siemens determined that the variance in temperature may cause differences in results, but not to the magnitude of the discordant results.Siemens further investigated the issue and determined that this issue was sample specific.Siemens determined that inadequate mixing, centrifugation, or other sample handling issues potentially contributed to the discordant, falsely elevated pt and pt inr results.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely elevated prothrombin time (pt) and pt international normalized ratio (inr) results were obtained on a patient sample, using the dade innovin reagent, on a sysmex ca-1500 system.The sample was automatically repeated using the same reagent and system, resulting higher and discordant, falsely elevated.The discordant, repeat results were reported to the physician(s), who questioned the results.The sample was re-centrifuged, mixed, and repeated using the same reagent lot and system, resulting lower.The patient was also sent to a different laboratory, where the patient's blood was redrawn.The result obtained on the new sample was 3.00 inr and this 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, falsely elevated pt and pt 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: 8233509
• Report Number: 9610806-2019-00002
• Device Sequence Number: 1624701
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/09/2019

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: 01/12/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR