MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT

Model Number	DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.(siemens) analyzed sysmex cs-5100 system backup files provided by the customer to determine the cause of the discordant, falsely low aptt results on the sysmex cs-5100 system.Siemens did not identify any systemic issues with the sysmex cs-5100 system.The cause of the event is unknown.The instrument and reagents are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2017-00083, mdr 9610806-2017-00084, mdr 9610806-2017-00085, and mdr 9610806-2017-00087 were filed for the same event.
Event or Problem Description
Two discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on a patient sample on the sysmex cs-5100 system.One result was obtained by mixing a test in a one-to-one dilution with the patient sample and the other was obtained by adding polybrene.These results were reported to the physician and it is unknown whether the physician questioned these results.On (b)(6) 2017, correct aptt results from other samples of the same patient were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt results.

• Brand Name: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Common Device Name: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 6789762
• Report Number: 9610806-2017-00086
• Device Sequence Number: 129515
• Product Code: GFO
• UDI-Device Identifier: 00842768003851
• UDI-Public: 00842768003851
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K760318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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: 11/30/2018
• Device Model Number: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Device Catalogue Number: 10445711
• Device Lot Number: 557236A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR