MAUDE Adverse Event Report: BECKMAN COULTER AU680 CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIRECT TRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the au680 chemistry analyzer, and identified the failure mode as hardware.Due to multiple hardware interventions performed, a definitive component could not be identified as the sole contributor of this event however there is sufficient evidence to suggest a hardware malfunction was the cause of this event.The customer replaced the sample probe prior to the arrival of the fse.The field service engineer replaced the r1 reagent syringe, ion selective electrode (ise) tubing, and ise buffer valve, which resolved the issue.Information not provided by customer.Initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported the generation of an erroneous low sodium (na) patient result on their au680 instrument.The result was not reported out of the laboratory.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient demographics.The customer verbally provided examples of the results.

• Brand Name: AU680 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: 10877884
• Report Number: 9612296-2020-00425
• Device Sequence Number: 3803251
• Product Code: JJE
• UDI-Device Identifier: 14987666542996
• UDI-Public: (01)14987666542996(11)180201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K961274
• 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): 11/20/2020

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: AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIRECT TRACK
• Device Catalogue Number: B96695
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1