MAUDE Adverse Event Report: BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU481-10, WIN7, CHEMISTRY ANALYZER AU480
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched and evaluated the device.The field service engineer (fse) replaced the sample probe inner wash valve to resolve the issue.Beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported erratic patient results generated for multiple analytes which included ualb (urine albumin), alp (alkaline phosphatase), cala (calcium), cre (creatinine), ggt (gamma-glutamyl transferase), gluc (glucose), tp (total protein), urea, d-dim (d- dimer), ua (uric acid) and observed sample probe diluting samples on system au480 clinical chemistry analyzer.The erroneous patient results were not reported out of laboratory.There was no change in patient treatment in association with this event.Quality control was within the laboratory¿s established ranges prior to event.
Additional Manufacturer Narrative
H10: upon further review of the risk assessment for creatinine, this event is not reportable.H10: upon further review of the risk assessment for creatinine, this event is not reportable.

• Brand Name: AU480 CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 11638336
• Report Number: 9612296-2021-00118
• Device Sequence Number: 14366808
• Product Code: JJE
• UDI-Device Identifier: 14987666542965
• UDI-Public: (01)14987666542965(11)170301
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K981743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AU481-10, WIN7, CHEMISTRY ANALYZER AU480
• Device Catalogue Number: B96692
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 03/28/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1