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

Model Number	DADE INNOVIN
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).There is no reports of error message on the sysmex cs-5100 systems.Siemens determined that pre-analytical issues (specific sample characteristics, blood collection, transportation, and/or sample processing/handling in the laboratory) potentially contributed to the discordant, falsely elevated prothrombin time (pt) expressed as pt sec and pt international normalized ratio (inr) results.Siemens specialists were previously dispatched to the customer's site to evaluate and discuss pre-analytical handling conditions with the customer.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) results expressed as pt seconds and pt international normalized ratio (inr) were obtained on a patient sample, using the dade innovin reagent, on a sysmex cs-5100 system.Additionally, a non-numerical pt % result was obtained on the sample.The sample was repeated three times using the same reagent and an alternate thromborel s reagent, resulting lower for pt seconds and pt inr.None of these results were reported to the physician(s).On the next day, a different sample from the patient was run on an alternate sysmex cs-5100 system, resulting lower for pt seconds and pt inr.The pt inr result of 1.25 was reported, as the correct result, to the physician(s).There is no report of adverse event nor treatment provided due to the discordant pt, pt inr, 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: 8444672
• Report Number: 9610806-2019-00041
• Device Sequence Number: 2818589
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• 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
• Report Date (Section B): 03/22/2019

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: 07/19/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR