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

Catalog Number	10445710
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.Has investigated the provided information to determine the cause of the falsely high activated partial thromboplastin time (aptt) patient results on multiple patients generated on a sysmex cs-5100 analyzer after quality control (qc) failure.No product non-conformance nor system issue could be identified.The instrument performed as expected.A high deviation of quality control was clearly displayed to the user.The deviation is visible for the affected (2) two days in the qc chart.The instrument and the qc protocol detected and displayed the issue.The customer did not adequately react to the qc error information in the pop-up window of the instrument screen.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2018-00018 was filed for the same event.
Event or Problem Description
Falsely high, flagged activated partial thromboplastin time (aptt) patient results on multiple patients were generated on a sysmex cs-5100 analyzer after quality control (qc) failure.These results were reported to the physician(s).The same patient samples were repeated on a different sysmex cs-5100 (with acceptable qc) and lower aptt patient results were generated.It is unknown if the repeat results were reported out to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant high, flagged patient results.

• Brand Name: DADE ACTIN FS ACTIVATED PTT REAGENT
• Common Device Name: DADE ACTIN FS ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 7228071
• Report Number: 9610806-2018-00017
• Device Sequence Number: 987551
• Product Code: GGW
• UDI-Device Identifier: 00842768003844
• UDI-Public: 00842768003844
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K811589
• 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): 01/30/2018

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: 05/30/2019
• Device Catalogue Number: 10445710
• Device Lot Number: 538530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1