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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

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BECKMAN COULTER COULTER AC T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem Not Applicable (3189)
Event Date 12/08/2015
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2015, the customer performed some troubleshooting to resolve the problems.For the aperture alerts and voteouts the customer was told to bleach the wbc count line and then was told to follow the procedure to adjust the aperture voltage ratio.It is unclear whether this aperture voltage ratio was changed due to the bleaching or if the instrument had the setting prior to troubleshooting.For the leak the customer was told to clean the probe wash block insert and shift tubing in valve lv8.After these steps in troubleshooting the customer reported that the instrument stopped leaking and there were no more alerts or voteouts.The probe leak was caused by poor scavenging of the probe wash.Cleaning the block and moving the in line pinch tubing cleared the restriction.The aperture alert/voteouts are most likely due to a clog in the aperture.Aperture targets can shift as the aperture and electrode wear.Setting the wbc target based on current data will prevent the problem from recurring.The customer technical support specialist who took this call provided additional information about the causes of the problems through email.The repairs were verified per established procedures.(b)(4).
 
Event Description
The customer reported aperture alerts, voteouts a contained leak of volume from the probe wash inside the coulter act diff 2 analyzer.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.The customer was wearing personal protective equipment (ppe) at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.
 
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Brand Name
COULTER AC T DIFF 2 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 33196
Manufacturer Contact
miranda holland
11800 sw 147th ave
32-s08
miami 33196
3053802031
MDR Report Key5333307
MDR Text Key34647427
Report Number1061932-2015-01809
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990352
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 12/08/2015
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 Number6605500
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2015
Initial Date FDA Received12/29/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2003
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
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