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Adverse Event Report

BECKMAN COULTER, INC. BECKMAN COULTER GEN.S SYSTEM HEMATOLOGY ANALYZER   back to search results
Model Number GEN.S
Event Date 08/05/2002
Event Type  No Answer Provided   Patient Outcome  Other;
Event Description

Customer reported that "when the diluent runs out, the instrument does not alarm until 4 or 5 samples have been analyzed and then shows a 'diluent low or faulty backwash tank float sensor' message. The 4 or 5 samples analyzed will have an error message and an incorrect very high platelet count". "an inexperienced operator validated some of these results without re-testing the samples. The results were reported to the customer's hematology consultant who found the results unbelievable and requested a repeat. ".

 
Manufacturer Narrative

1. 8/28/2002: attempts were made at bci to reproduce the problem using an lh and gen. S analyzer. Service could not replicate the problem stated by the customer. Only two cycles could be executed after the backwash tank error, instead of 5 cycles. 2. 8/29/2002: requested raw data from customer and error log. None of the requested materials were received from the customer. 3. 9/18/2002: service visited account and tried to replicate customer complaint. Investigation results were the same as #1 above. Parameter: wbc, reference run (before backwash tank error) 9/17/2002 13:10:15: 19. 6, reference run (after backwash tank error) 9/17/2002 13:10:53: 20. 8; patameter: rbc, reference run (before backwash tank error) 9/17/02 13:10:15: 4. 16, reference run (after backwash tank error) 9/17/02 13:10:53: 7. 57; parameter: hgb, reference run (before backwash tank errr) 9/17/02 13:10:15: 13. 3, reference run (after backwash tank error) 9/17/02 13:10:53: 14; parameter: plt, reference run (before backwash tank error) 9/17/02 13:10:15: 412, reference run (after backwash tank error) 9/17/02 13:10:53: 687. 4 conclusions: 4. 1 the bottom liner of the diluent container creates wrinkles and prevents the diluent level sensor to activate when the container is empty. 4. 2 the issue of wrinkles created at the bottom of the diluent container has only been observed in the european containers. These containers use a double-liner construction and the inner liner separates from the outer liner which creates wrinkles that prevents the float in the level sense from activating properly. 4. 3 further investigation of this item is in progress. Customer has two instruments but has not yet confirmed which instrument experienced the reported incident.

 
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Brand NameBECKMAN COULTER GEN.S SYSTEM
Type of DeviceHEMATOLOGY ANALYZER
Baseline Brand NameBECKMAN COULTER GEN.S SYSTEM
Baseline Generic NameHEMATOLOGY ANALYZER
Baseline Catalogue Number6605381
Baseline Model NumberGEN.S
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BECKMAN COULTER, INC.
11800 sw 147th st
miami FL 33196
Manufacturer (Section D)
BECKMAN COULTER, INC.
11800 sw 147th st
miami FL 33196
Manufacturer Contact
sheri hall manager
200 s. kraemer blvd
brea , CA 92622-8000
(714) 993 -8916
Device Event Key410869
MDR Report Key421816
Event Key398950
Report Number1023939-2002-00005
Device Sequence Number1
Product CodeGKZ
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 10/04/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL NumberGEN.S
Device Catalogue Number6605381
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2000
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on January 30, 2009

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