BERICHROM ANTITHROMBIN III
Received Oct 30, 2017 · Event occurred Oct 5, 2017
Report 9610806-2017-00119 · MDR key 6986810
Device
Generic name
Berichrom Antithrombin Iii
Manufacturer
Siemens Healthcare Diagnostics Products GmbhCatalog number
10446672
Lot number
46999
Product problems
- Low Test Results
- Low Test Results
Patient
45 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE PROVIDED INFORMATION TO DETERMINE THE CAUSE OF THE DISCORDANT, LOW ATIII PATIENT SAMPLE RESULT ON THE ATELLICA COAGULATION 360 SYSTEM. NO PRODUCT NON-CONFORMANCE COULD BE IDENTIFIED AND A POSSIBLE CAUSE OF THE EVENT MAY BE RELATED TO SAMPLE HANDLING. THE INSTRUMENT AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.
Description of Event or Problem
A DISCORDANT, LOW BERICHROM ANTITHROMBIN III (ATIII) PATIENT SAMPLE RESULT OF <15% WAS GENERATED ON THE ATELLICA COAG 360 SYSTEM AND WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED AGAIN ON THE SAME SYSTEM AND AN ATIII RESULT OF 95.2% WAS GENERATED. THE SAME PATIENT SAMPLE WAS REPEATED ON A BCS XP SYSTEM AND AN ATIII RESULT (NOT PROVIDED BY CUSTOMER) WAS GENERATED THAT WAS CONSISTENT WITH THE 95.2% RESULT ON THE ATELLICA COAG 360 SYSTEM. ALL QUALITY CONTROL RESULTS WERE WITHIN RANGE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, LOW ATIII RESULT.