MalfunctionGKF
STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2
Received Jun 19, 2017 · Event occurred May 18, 2017
Report 1219029-2017-00006 · MDR key 6651879
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
54 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE CUSTOMER COMPLAINT INFORMATION CONFIRMED THAT THE PATIENT WAS NOT MISTREATED DUE TO THE IDENTIFIED SOFTWARE ISSUE. NOVA HAS ALSO CONFIRMED THAT THIS IS THE FIRST COMPLAINT THAT WE HAVE RECEIVED DUE TO THIS REPORTED SOFTWARE ISSUE. DECISION TO INITIATE A FIELD CORRECTION TO IMMEDIATELY CORRECT THE SOFTWARE ISSUE ASSOCIATED WITH THE USE OF STAT PROFILE PRIME AUTO-CARTRIDGE QUALITY CONTROL (A-QC) MATERIALS. THE INVESTIGATION IS CURRENTLY IN PROCESS.
Description of Event or Problem
PRIME ANALYZER S/N (B)(4) FAILING TO FLAG A PATIENT CRITICAL PH LEVEL.
Remedial action
- Modification/Adjustment
- Notification