FDA.reportPublic FDA data

MAUDE MDR 2032175

MDR report key
2032175
Report number
1061932-2011-00197
Event key
0
Event type
3
Date of event
2011-02-26
Date received
2011-03-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS NORA ZEROUNIAN
Address
250 S KRAEMER BOULEVARD BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COULTER LH 750 ANALYZERAUTOMATED DIFFERENTIAL CELL COUNTERBECKMAN COULTER INC.LOQLH 7506605632N/AY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-290

Event Narratives#

N

Patient 1

CUSTOMER WS RUNNING CONTROLS DURING THE TIME OF EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPAIRED THE LEAK AT THE STAIN PUMP. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

D

Patient 1

A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATED THAT UPON TROUBLESHOOTING (TS) A RETIC VOTEOUT ISSUE ON THE COULTER LH 750 ANALYZER, A LEAK WAS OBSERVED THAT SEEMED TO BE A RETIC STAIN. THERE WAS NO REPORT OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT. THE OPERATOR DID NOT SEEK MEDICAL TREATMENT AND THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.