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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field application specialist (fas) was dispatched and evaluated the device.The fas replaced a bent sample probe to resolve the issue.Beckman coulter internal identifier is (b)(4).Patient demographic information was not provided.Patient data was not provided.(b)(6).
Event or Problem Description
The customer reported intermittent low glucose (glu), creatinine (cre), and alanine aminotransferase (alt) patient results on the au480 clinical chemistry analyzer.The results were not reported out of the laboratory.There was no change in patient treatment in association with this event.Quality control (qc) were within laboratory¿s established range prior to and after the event.

• 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 8000
• MDR Report Key: 11206333
• Report Number: 9612296-2021-00012
• Device Sequence Number: 16692063
• 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
• Report Date (Section B): 01/20/2021

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1