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

Catalog Number 10484200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics personnel 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 a drifting baseline which was flagged according to the algorithm.Results with pathromtin sl are either "no clot" or prolonged and are an indication of a coagulation disorder.A difference between the results obtained on the bcs xp system and the cs-5100 system may be due to the differences in method application used and differences in the clot detection algorithms.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2017-00089 was filed for the same event.

Event Description

High activated partial thromboplastin time (aptt) results on one patient sample were generated on the sysmex cs-5100 analyzer (serial number (b)(4)) using the pathromtin sl assay (initial result and repeat results 1, 3, and 4) versus the actin fs assay (repeat result 2).The initial aptt result of >160sec was reported to the physician who did not question the result.The actin fs assay aptt repeat result 2 of 23.7sec was also reported to the physician.It is unknown what the expected aptt result should have been for the patient.The same sample and system were used for tesing with both assays.All qc recovery was acceptable.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 on august 11, 2017.November 15, 2017 corrected data: the pathromtin® sl reagent (catalog number 10484200), is not registered in the united states (u.S.).The pma/510k number, k955450, corresponds to the u.S.Specific reagents.The pathromtin® sl reagents registered for use in the u.S.Have catalog numbers 10446066 and 10446067, pma/510k number k955450, and a unique device identifier (udi) number (b)(4).

• 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: 6789793
• MDR Text Key: 82709032
• Report Number: 9610806-2017-00088
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2018
• Device Catalogue Number: 10484200
• Device Lot Number: 536695
• 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: 01/18/2017
• 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: 57 YR