MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-06 for COULTER LH 755 ANALYZER 6605732 manufactured by Beckman Coulter, Inc..
[16534001]
A customer contacted beckman coulter inc. (bci) in regards to erroneously high wbc result with no instrument generated flags when compared to the repeat run on the coutler lh 755 instrument. The repeat run was consistent with the lower wbc obtained by manual count which the lab considers correct. No erroneous results were reported out of the laboratory. There was no death, injury, or change to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[16661471]
Sample collection and storage information were not provided for this investigation. Controls were run before and after the event. The unit is currently performing within qc specifications with respect to controls. Raw data analysis revealed that the raw count rate for run 1 is significantly higher than run 2. The difference in the raw counts is directly related to the differences in the wbc results. Moreover, the raw count rate trends down with collection time for run 1 while it remained flat for run 2. A bci field service engineer (fse) replaced the following components: vl3no tube, sol21, check valve, and vl10. Fse stated up verification passes. Ran patient specimens for system verification purposes. Root cause is most likely attributed to the parts that were replaced for the system diluter during the instrument servicing performed subsequent to this cf event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00239 |
| MDR Report Key | 2042148 |
| Report Source | 05 |
| Date Received | 2011-04-06 |
| Date of Report | 2011-03-02 |
| Date of Event | 2011-02-01 |
| Date Mfgr Received | 2011-03-02 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2012-02-16 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| 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 755 ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-04-06 |
| Model Number | LH 755 |
| Catalog Number | 6605732 |
| 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 | 2011-04-06 |