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

Model Number AU481-10E CHEMISTRY ANALYZER AU480 WITH ISE

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The customer performed their own troubleshooting with the support of beckman field service engineer and evaluated the analyzer.The customer re-seated the electrodes, cleaned the blocks, and replaced ise tubing to resolve the issue.The customer performed calibration and quality control, which all passed.The customer verified the analyzer resumed to normal operation.Section a2, a4, and a5: information not provided by customer.Beckman coulter internal identifier is case(b)(4).

Event Description

The customer reported two patients had low sodium (na) and chloride (cl) results on their au480 clinical chemistry analyzer.The customer repeated the patient samples and obtained normal results.The customer released the correct results 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 provided the results for two patients.

• Brand Name: AU480 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 18959590
• MDR Text Key: 338748275
• Report Number: 9612296-2024-00103
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666540671
• UDI-Public: (01)14987666540671(11)160415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU481-10E CHEMISTRY ANALYZER AU480 WITH ISE
• Device Catalogue Number: B12183
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1