AU480 CLINICAL CHEMISTRY ANALYZER
Received May 11, 2018 · Event occurred May 17, 2017
Report 9612296-2018-00212 · MDR key 7505733
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter Mishima K.kModel number
AU480Catalog number
B12183
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: A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED INSTRUMENT. IF BECKMAN RECEIVES ANY INFORMATION THAT IS RELEVANT TO THE SUBMISSION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT.
Description of Event or Problem
THE COMPLAINANT REPORTED THAT THE INSTRUMENT EXPERIENCED PROBLEMS WITH ION-SELECTIVE ELECTRODE (ISE) HAVING SCATTERED RESULTS FOR POTASSIUM MEASUREMENTS. 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.