MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-27 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[20734146]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer gave erroneously high reticulocyte of 50 with an r flag. The customer performed a manual count and obtained a correct result of 1. 1. No erroneous results were reported out of the laboratory. The result of the manual count was accepted as the correct result and was reported out. There was no death, injury, or change to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[20828464]
The instrument is currently within qc specifications with respect to controls (accuracy) and repeatability (precision). Controls were run before the cf event; all recovered within assay limits, controls were not ran after the event. A field service engineer (fse) was dispatched and replaced the red strip tubing for the stain and retic mixing chambers. The fse also replaced the diff and retic sample lines to the flow cell. The customer was instructed to "prime" before running baby samples to help avoid excessive r flags. The root cause is instrument related as the fse had to replace hardware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00308 |
| MDR Report Key | 2071298 |
| Report Source | 06 |
| Date Received | 2011-04-27 |
| Date of Report | 2011-03-28 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-03-28 |
| Date Added to Maude | 2011-05-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 750 ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-04-27 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-27 |