MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH TEST THROMBIN REAGENT

Catalog Number OWHM

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

A customer running a lab for remote samples was contacted by one of his clients that a surgery had been postponed based on a potentially falsely prolonged thrombin time (tt) result.The patient result was reported to the physician.It is unknown if patient treatment was otherwise altered or prescribed on the basis of the potentially falsely prolonged thrombin time (tt) result.There is no report of adverse outcome to the patients as a result of the potentially falsely prolonged thrombin time (tt) result.

Manufacturer Narrative

The cause of the discrepant potentially falsely prolonged thrombin time (tt) result is unknown.The affected sample material was not available for internal investigation.However, investigation with other samples is ongoing to assess a potential for prolonged tt results in sec.Based on qc and the device function with other assays and parameters, there is no indication for a potential performance issue with the sysmex ca-7000 instrument.The instrument is performing within specifications.

• Brand Name: TEST THROMBIN REAGENT
• Type of Device: TEST THROMBIN REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 3504 1; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 4732547
• MDR Text Key: 5705786
• Report Number: 9610806-2015-00009
• Device Sequence Number: 1
• Product Code: GJA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K930157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 06/12/2016
• Device Catalogue Number: OWHM
• Device Lot Number: 44083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1