MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH THROMBOREL S

Catalog Number	10446445
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The delay in the prothrombin time (pt) / international normalized ratio (inr) patient results to the physician was the result of a user error.The sysmex cs-2100i system was programmed to run a reflex test (secondary test) for thrombin clotting time (tct) when an inr >7 was generated.The pt/inr patient results were not transmitted to the laboratory's host system and delayed due to an incomplete deactivation by the user of the reflex test existing in an older, inactive user defined method (udm) protocol for the tct assay.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Prothrombin time (pt) / international normalized ratio (inr) initial patient results were generated and delayed on the sysmex cs-2100i system.The delay in the pt / inr initial patient results to the physician resulted in the patient receiving their normal dose of warfarin when in fact the patient's inr was high.The same sample was repeated twice on the same system when the user discovered the pt/inr patient result delay on the sysmex cs-2100i system.The repeat pt patient results were 127.8 sec and 138.1 sec.The patient was sent to the emergency room for appropriate vitamin k treatment and was released the next day.There was no known negative impact or adverse health consequence to the patient due to the vitamin k treatment.

• Brand Name: THROMBOREL S
• Common Device Name: THROMBOREL S
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 6770133
• Report Number: 9610806-2017-00077
• Device Sequence Number: 11105334
• Product Code: GJS
• UDI-Device Identifier: 00842768011337
• UDI-Public: 00842768011337
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2017
• Device Catalogue Number: 10446445
• Device Lot Number: 546913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1