AU5800 CHEMISTRY ANALYZER
Received Sep 25, 2018 · Event occurred May 2, 2016
Report 9612296-2018-00306 · MDR key 7906796
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter Mishima K.kModel number
AU5800Catalog number
A94907
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE COMPLAINANT REPORTED THAT THE INSTRUMENT EXPERIENCED PROBLEMS WITH INACCURATE OR ERRONEOUS RESULTS, ION-SELECTIVE ELECTRODE (ISE) . 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.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST RECEIVED ON 25 MAY 2023. THE INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4). THIS CF HAS BEEN ENTERED AS PART OF THE COMPLAINT RETROSPECTIVE REVIEW. BASED ON INVESTIGATION OF THE SERVICE RECORD FOR THIS EVENT, HARDWARE WAS DEEMED AS THE CONFIRMED FAILURE MODE FOR THE ERRONEOUS ISE RESULTS.