VITROS IMMUNODIAGNOSTICS PRODUCTS NT-PROBNP REAGENT PACK
Received Apr 29, 2015 · Event occurred Apr 8, 2015
Report 3007111389-2015-00101 · MDR key 4737157
Device
Generic name
In-vitro Diagnostic
Manufacturer
Ortho-clinical DiagnosticsCatalog number
6802156
Lot number
1250
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION CONFIRMED THAT A NONREPRODUCIBLE, HIGHER THAN EXPECTED VITROS NTPROBNP RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS NTPROBNP REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THE CUSTOMER'S VITROS 5600 SYSTEM OR VITROS NT-PROBNP REAGENTS HAD MALFUNCTIONED.
Description of Event or Problem
THE CUSTOMER COMPLAINED OF A NONREPRODUCIBLE, HIGHER THAN EXPECTED VITROS NTPROBNP RESULT FROM A SINGLE PATIENT SAMPLE USING VITROS NTPROBNP REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT RESULT: 513 PG/ML VS EXPECTED 81.8 PG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULT WAS NOT REPORTED TO A CLINICIAN AND NO ALLEGATION OF PATIENT HARM WAS MADE AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).