AU5800 CLINICAL CHEMISTRY ANALYZER
Received May 11, 2018 · Event occurred Oct 10, 2017
Report 9612296-2018-00222 · MDR key 7505736
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter Mishima K.kModel number
AU5800Catalog number
B23280
Lot number
N/A
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(6). NOTE: BECKMAN COULTER IS CONDUCTING A RETROSPECTIVE REVIEW OF ITS GLOBAL SERVICE RECORDS, TO ENSURE THAT THE RECORDS HAD BEEN ADEQUATELY EVALUATED FOR POTENTIAL COMPLAINT INFORMATION AND ANY WARRANTED FOLLOW-UP ACTION, INCLUDING MDR REPORTING. THIS MDR REPORT IS A RESULT OF THAT RETROSPECTIVE REVIEW. MANUFACTURING INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE AU5800 CLINICAL CHEMISTRY ANALYZER WAS EVALUATED AT THE USER FACILITY BY A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE). INSTRUMENT FUNCTIONAL CHECKS WERE PERFORMED WHICH IDENTIFIED ERRONEOUS RESULTS. THE SERVICE DOCUMENTATION REVEALED THAT THE FSE PERFORMED MAINTENANCE ON THE ION PIPING SYSTEM AND CALIBRATION WHICH RESOLVED THE ISSUE. FOLLOWING THE SERVICE ACTIVITY, THE INSTRUMENT WAS RESTORED TO FULL FUNCTIONALITY. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE FAILURE MODE. THE FSE IDENTIFIED POOR ION PIPING SYSTEM. THEREFORE, THE COMPLAINT EVENT WAS CONFIRMED.
Description of Event or Problem
THE COMPLAINANT REPORTED THAT THE INSTRUMENT EXPERIENCED PROBLEMS THE ION MODULE RESULT IS LOW , INACCURATE OR ERRONEOUS RESULTS. THERE WAS NO REPORT OF PATIENT RESULTS RELEASED FROM THE LABORATORY. NO PATIENT CONSEQUENCES OR ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT. NO CALIBRATION DATA WAS SUPPLIED FOR THIS INCIDENT. THE COMPLAINT DEVICE WAS AVAILABLE FOR EVALUATION.