Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE Back to Search Results
Model Number AU481-10
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2017
Event Type  malfunction  
Manufacturer Narrative
Beckman coulter field service engineer (fse) evaluated the system.The fse replaced the electrolyte reference electrode to resolve the issue.(b)(64.
 
Event Description
The customer's au480 clinical chemistry analyzer generated erroneous na( sodium) results for one patient sample.Customer reported quality control was erratic.There was no impact to patient treatment.The results was not reported outside the lab.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AU480 CLINICAL CHEMISTRY ANALYZER
Type of Device
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
Manufacturer (Section D)
BECKMAN COULTER
250 s. kramer blvd
brea CA 92821 8000
Manufacturer (Section G)
BECKMAN COULTER MISHIMA K. K
beckman coulter mishima k.k
452-32 higashino
JP-NO TA 4
JA   JP-NOTA 41
Manufacturer Contact
david davis
250 s. kraemer blvd.
m/s e1.se.01
brea, CA 92821-8000
7149613796
MDR Report Key6709014
MDR Text Key80073856
Report Number9612296-2017-00026
Device Sequence Number0
Product Code JGS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112412
Number of Events Reported1
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 06/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAU481-10
Device Catalogue NumberB11810
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-