MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-02-24 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1711953]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer generated erroneously high platelet (plt) results on three (3) different patients. It is unknown if the instrument generated flags or error messages because patient printouts were not provided. Erroneous results were reported out of the laboratory. Patients 1 and 2 were rerun 24 hours later and the rerun results were also erroneously high. Both patients were redrawn and the platelet results recovered lower, which the customer considers correct. No data for the third patient was provided. Amended reports were issued. There was no death, injury, or change to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8946358]
The specimens were collected in 4ml bd vacutainer tubes and sampled within 30 minutes of collection. No manual platelet estimates or counts were performed on these three patient specimens. The same lot # was used for the specimen collection for all three patient specimens. All three patient specimens were collected by different phlebotomists. Controls were run before the event and recovered within assay limits. The instrument is currently within qc specifications with respect to controls (accuracy) and reproducibility (precision). A field service engineer (fse) was dispatched and was unable to reproduce the problem while on site. The fse collected the raw data and verified instrument performance. The root cause is unknown to date for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00103 |
| MDR Report Key | 2001074 |
| Report Source | 06 |
| Date Received | 2011-02-24 |
| Date of Report | 2011-01-25 |
| Date of Event | 2011-01-25 |
| Date Mfgr Received | 2011-01-25 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2012-02-08 |
| 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 | IN |
| 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 | 2011-02-24 |
| 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 | 2011-02-24 |