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

Catalog Number 10445710

Device Problem High Test Results (2457)

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

Event Date 01/05/2018

Event Type  malfunction  

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 9610806-2018-00017 was filed for the same event.

Event 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
• Type of Device: DADE ACTIN FS 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: 7228075
• MDR Text Key: 98645907
• Report Number: 9610806-2018-00018
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003844
• UDI-Public: 00842768003844
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K811589
• 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
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 10445710
• Device Lot Number: 538530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2017
• 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