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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) was dispatched and evaluated the au680 chemistry analyzer.The fse confirmed 8 out of 200 samples were affected.The fse determined the failure mode to be a defective buffer valve.The fse replaced the buffer valve to resolve the issue.Information not provided by customer.Initial reporter telephone number is (b)(6).The beckman coulter internal identifier is case-(b)(4).
Event or Problem Description
A customer reported the generation of erroneous ion-selective electrolytes (ise) results for eight (8) patient samples on their au680 chemistry analyzer.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient demographics or data.

• 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
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; SCHIZ UOKA; JA SCHIZUOKA
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 13931430
• Report Number: 9612296-2022-00119
• Device Sequence Number: 11763159
• Product Code: JJE
• UDI-Device Identifier: 14987666542996
• UDI-Public: (01)14987666542996(11)171001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown