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	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.There were no issues with other patient samples.No hardware errors occurred at the time of the event.The customer suspected a possible blood collection issue because the sample was sent in for testing and not collected on site.Inadequate mixing, centrifugation or other mishandling of the sample cannot be excluded as contributing factors to the discordant results.The sample tube manufacturer's instructions for use (ifu) must be followed, including mixing of the sample after phlebotomy, to ensure complete dispersion of the anti-coagulant throughout the sample to avoid latent fibrin formation in the plasma portion of the sample.The issue is sample specific, but the specific cause of the discordant results cannot be determined.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00037 was filed for the discordant prothrombin time result obtained on 09-jul-2020.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) result was obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The discordant result was not reported to the physician(s).The same sample was repeated on the same system using the same reagent, resulting lower.This result was reported, as the correct result, to the physician(s).The following day, another discordant, falsely elevated pt result was obtained on another sample from the same patient on the same sysmex ca-660 system using dade innovin reagent.The discordant result was not reported to the physician(s).The patient was redrawn and the redrawn sample was run for pt on the same sysmex ca-660 system using dade innovin reagent, resulting lower.This result was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) 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: 10367914
• Report Number: 9610806-2020-00036
• Device Sequence Number: 19441233
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• 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): 08/05/2020

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: 01/31/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 549729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1