INNOVANCE(R) ANTITHROMBIN REAGENT
Received Jan 8, 2013 · Event occurred Dec 9, 2012
Report 9610806-2013-00001 · MDR key 2901348
Device
Generic name
Innovance(r) Antithrombin Reagent
Manufacturer
Siemens Healthcare Diagnostics Products GmbhCatalog number
OPFH
Lot number
41736
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER COMPLAINS OF DECREASING QC VALUES FOR INNOVANCE ANTITHROMBIN (AT) WITH RESULTS DECREASING OUT OF ACCEPTANCE RANGES AFTER 24 HOURS. IT IS UNKNOWN IF PATIENT SAMPLES WERE REPORTED. THE CUSTOMER REPORTS THEY HAVE SWITCHED TO TESTING ON AN ALTERNATE INSTRUMENT SYSTEM. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF FALSELY DEPRESSED AT RESULTS. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE FALSELY DEPRESSED RESULTS.
Additional Manufacturer Narrative
THE CAUSE OF THE FALSELY DEPRESSED ANTITHROMBIN RESULTS IS UNKNOWN. THE REAGENT ISSUE IS UNDER INVESTIGATION BY SIEMENS HEALTHCARE DIAGNOSTICS INC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.