AU5800 CLINICAL CHEMISTRY ANALYZER
Received May 11, 2018 · Event occurred Oct 21, 2016
Report 9612296-2018-00211 · MDR key 7505735
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter Mishima K.kModel number
AU5800Catalog number
A94907
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 BUFFER SYRINGE TO BE WORN AND LEAKING. THE SERVICE DOCUMENTATION REVEALED THAT THE FSE REPLACED THE BUFFER SYRINGE 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 ISE RESULTS. THEREFORE, THE COMPLAINT EVENT WAS CONFIRMED.
Description of Event or Problem
THE COMPLAINANT REPORTED THAT THE INSTRUMENT EXPERIENCED PROBLEMS WITH CHEMISTRY PERFORMANCE WITH ION-SELECTIVE ELECTRODE (ISE) MEASUREMENT OF SODIUM. 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.