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

Model Number	DADE INNOVIN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that five different prothrombin time (pt) results and five different prothrombin time international normalized ratio (inr) results were obtained on one patient sample on a sysmex ca-620 system using dade innovin reagent.Quality controls (qc) recovered within range at the time of the event, and only results from one patient sample were reported to be discordant.The customer declined to provide further information, so siemens could not evaluate the cause of different pt and inr results on this one patient sample.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Five different prothrombin time (pt) results and five different prothrombin time international normalized ratio (inr) results were obtained on one patient sample on a sysmex ca-620 system using dade innovin reagent.None of the results were reported to the physician(s), and it is unknown if a redrawn sample was obtained.It is unknown which of the results are discordant.There are no reports of patient intervention or adverse health consequences due to the discordant prothrombin time and prothrombin time international normalized ratio 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: 8934809
• Report Number: 9610806-2019-00069
• Device Sequence Number: 13937608
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/27/2019

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: 11/16/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1