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

Model Number AU681-10E, CHEMISTRY ANALYZER AU680 WITH ISE

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Beckman coulter field service engineer (fse) evaluated the au680 chemistry analyzer, and identified the failure mode as a cracked sample syringe case.The fse replaced the sample syringe case to resolve the issue.The beckman coulter internal identifier is (b)(4).

Event Description

The customer reported the generation of zero (0) patient results for bun (blood urea nitrogen), glu (glucose) and calc (calcium) on their au681-10e, chemistry analyzer.The erroneous patient results were not reported out of laboratory.There was no affect to patient treatment in connection to event.Quality control was within the laboratory¿s established ranges prior to event.Customer did not provide data for review.

• Brand Name: AU680 CHEMISTRY ANALYZER
• Type of Device: 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; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 10475043
• MDR Text Key: 205725935
• Report Number: 9612296-2020-00308
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 14987666540725
• UDI-Public: (01)14987666540725(11)160401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2020

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
• Device Operator: Health Professional
• Device Model Number: AU681-10E, CHEMISTRY ANALYZER AU680 WITH ISE
• Device Catalogue Number: B12188
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/20/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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