VITROS MALB REAGENT
Received Jul 16, 2010 · Event occurred Jan 28, 2010
Report 1319808-2010-00014 · MDR key 1759974
Device
Generic name
In Vitro Diagnostic
Manufacturer
Ortho-clinical DiagnosticsCatalog number
6801740
Lot number
1505-04-9484
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS MALB RESULTS FOR THREE PATIENT SAMPLES WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE ORIGINAL RESULTS WERE REPORTED TO THE CLINICIAN. THERE WERE NO ALLEGATIONS OF HARM TO THE PATIENTS AS A RESULT OF THESE EVENTS. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES (THREE REPORTED FALSE NEGATIVE RESULTS FROM THE CUSTOMER) WERE INVOLVED. (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION CONFIRMED THAT LOWER THAN EXPECTED VITROS MALB PATIENT RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS ANALYZER. A DEFINITIVE ROOT CAUSE HAS NOT BE DETERMINED. HOWEVER, AN ANTIGEN EXCESS EFFECT IN THE PRESENCE OF ELEVATED ALBUMIN LEVELS IN THE PATIENT SAMPLES CANNOT BE RULED OUT. THE INVESTIGATION INTO VITROS MALB REAGENT PERFORMANCE IS ONGOING.