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

Catalog Number B4219-2 SMN 10445714

Device Problem Use of Device Problem (1670)

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

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the reported incident, the administration of an extra dose of heparin is the discrepancy between therapeutic range values for heparinized patients between two facilities.There is no indication of erroneous results reporting by the complainant facility, (b)(6).This first facility follows the general recommendations for performing heparin therapeutic range testing with every change between old and new lots of aptt reagents and tracking the cumulative difference between lots.Siemens healthcare has provided the second facility, (b)(6), with the 2014 siemens white-paper on therapeutic heparin testing to evaluate their current practices.The actin fsl aptt reagent is performing within specifications.No further evaluation of the device is required.

Event Description

A change in treatment which occurred due to differences in activated partial thromboplastin time (aptt) heparin therapeutic ranges between two hospital facilities.A patient with an aptt result within the therapeutic range at the first facility was transferred to a second hospital facility.A medic involved in the transfer regarded the aptt result as low relative to the heparin therapeutic range at the second hospital facility.The patient was administered an extra dose of heparin based on the difference in therapeutic ranges.There is no indication that patient treatment was altered or prescribed on the basis of the difference in therapeutic ranges or the additional heparin dose administered.There was no report of adverse health consequences as a result of the difference in therapeutic ranges or the additional heparin dose administered.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5651770
• MDR Text Key: 45100024
• Report Number: 9610806-2016-00018
• Device Sequence Number: 1
• Product Code: GGW
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/21/2017
• Device Catalogue Number: B4219-2 SMN 10445714
• Device Lot Number: 547468A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2016
• Date Device Manufactured: 07/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR