• 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 COULTER LH500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

  • 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 COULTER LH500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number N/A
Device Problem Improper Device Output (2953)
Patient Problem Not Applicable (3189)
Event Date 10/10/2016
Event Type  malfunction  
Manufacturer Narrative
On 09/12/2016 the field service engineer (fse) reported that the blood sampling valve was not aligning properly causing the voteouts and no diffs.The fse replaced the bsv and actuator to resolve the issue.The repairs were verified per established procedures.(b)(4).
 
Event Description
The customer reported that the controls were not within range on the coulter lh500 hematology analyzer.There were diff voteouts and no diff on samples at the time of the event.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COULTER LH500 HEMATOLOGY ANALYZER
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECKMAN COULTER
250 south kraemer blvd.
brea CA 92821
Manufacturer (Section G)
BECKMAN COULTER
11800 sw 147th ave
miami FL 33196
Manufacturer Contact
miranda holland
11800 sw 147th ave
32-s08
miami, FL 33196
3053802031
MDR Report Key6076573
MDR Text Key59076074
Report Number1061932-2016-00893
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042724
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 10/10/2016
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 NumberN/A
Device Catalogue Number178833
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2016
Initial Date FDA Received11/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
-
-