MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PATHROMTIN SL

Catalog Number 10446067

Device Problem High Test Results (2457)

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

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics reviewed the backup files provided by the customer of the sysmex cs-5100 analyzer to determine the cause of the high activated partial prothrombin time (aptt) result.Review of the sysmex cs-5100 analyzer backup file included analysis of the cs-5100 kinetics, which showed no issues and no error codes were triggered.The system operated as specified and a non-conformance could not be identified.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, high activated partial thromboplastin time (aptt) result of 115 seconds on one patient sample was generated on the sysmex cs-5100 analyzer using the pathromtin sl assay (lot 536693).This result was not reported to the physician.The same sample, using a different lot of pathromtin sl reagent (lot 536695), was tested on a bcs xp system generating an aptt result of 35.5 seconds.This result was in line with the clinical picture of the patient.There are no reports of patient intervention or adverse health consequence due to the high aptt result.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr 9610806-2017-00105 on september 29, 2017.November 15, 2017 corrected data: the lot number and siemens material number (or catalog number) listed were incorrect on the initial mdr filed on september 29, 2017.The correct lot number is 536693a and the correct catalog number is 10446067.Updated accordingly.The expiration date and unique identifier (udi) do not change.

• Brand Name: PATHROMTIN SL
• Type of Device: PATHROMTIN SL
• 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: 6904643
• MDR Text Key: 89422537
• Report Number: 9610806-2017-00105
• Device Sequence Number: 1
• Product Code: GFO
• UDI-Device Identifier: 00842768007538
• UDI-Public: 00842768007538
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2018
• Device Catalogue Number: 10446067
• Device Lot Number: 536693A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2016
• 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
• Patient Age: 83 YR