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	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) 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 the sysmex cs-2100i system.The customer indicated that there was no issue with the patient's blood collection and that the sample tube was sufficiently filled; there were no clots in the sample.As per the sysmex cs-2000i/cs-2100i instructions for use (ifu), "extrapolation boundary over" is triggered when "the analysis results exceeded the calibration curve extrapolation range" or when "the analysis results fell below the calibration curve extrapolation range." the ifu recommends the user to change the dilution ratio and repeat the analysis.A siemens field service engineer (fse) was dispatched to the customer's site.During this visit, the fse cleaned the sample and reagent probes and aligned the probes and optics.Siemens also changed the sample tube type on the system's software.Siemens reviewed the sysmex cs-2100i system's back up files and did not find any issue.Siemens determined that maintenance was regularly performed on the system and that quality controls (qcs) were within expected ranges on the day of the event.Siemens also determined that the reaction kinetics of the affected measurements were correctly evaluated by the system.Siemens concluded that a pre-analytical issue or sample specific issue potentially contributed the discordant, falsely elevated pt inr and pt results.The system and reagent are performing according to specifications.No further evaluation of these devices is required.
Event or Problem Description
Flagged non-numerical prothrombin time (pt) international normalized ratio (inr) and pt % results and a discordant, falsely elevated pt result were obtained on a patient sample on a sysmex cs-2100i system, using the dade innovin reagent.The sample was repeated on the same system, using the same reagent lot (in extended time), and discordant, falsely elevated pt inr and pt results were obtained on the patient sample.The sample was repeated in micro-mode on the same system, using the same reagent lot, resulting lower for pt inr and pt.None of these results were reported to the physician(s).The patient's blood was re-drawn and the new sample was repeated on the same system and reagent lot; the results obtained on the new sample were lower than the discordant results and the pt inr 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 inr and pt results.
Additional Manufacturer Narrative
Additional information (16-nov-2018): siemens received the investigation results from the legal manufacturer of the sysmex cs-2100i system.The legal manufacturer determined that the incorrect sample tube type setting was selected on the sysmex cs-2100i system when the discordant results were obtained on the patient sample.

• 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: 8005667
• Report Number: 9610806-2018-00108
• Device Sequence Number: 1311262
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 09/01/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 539395A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR