MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT; DADE ACTIN FSL ACTIVATED PTT REAGENT

Catalog Number 10445714

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, high activated partial thromboplastin time (aptt) patient result generated on the sysmex ca-660 analyzer.Siemens requested the customer to perform a precision study and no product non-conformance nor system issue could be identified.A possible potential cause of the event may be related to sample handling or the nature of the sample.The cause of the discordant high aptt result on the sysmex ca-660 analyzer is unknown.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant high activated partial thromboplastin time (aptt) patient result of 184.1sec was generated on a sysmex ca-660 analyzer.This result was not reported.The same sample was repeated on the same system (sysmex ca-660 analyzer) and an aptt patient result of 109sec (repeat result 1) was generated.This result was not reported.The same sample was repeated on a sysmex ca-560 analyzer and an aptt patient result of 103sec (repeat result 2) was generated and reported to the physician.All results were run on the same day ((b)(6) 2017) on the same patient sample.There are no reports of patient intervention or adverse health consequence due to the discordant high aptt patient result.

• Brand Name: DADE ACTIN FSL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• Manufacturer Contact: loriann russo ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242287
• MDR Report Key: 7176116
• MDR Text Key: 96827780
• Report Number: 9610806-2018-00009
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2018
• Device Catalogue Number: 10445714
• Device Lot Number: 547494A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1