MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-03 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1853270]
A customer contacted beckman coulter inc. (bci) stating that the coutler lh 750 analyzer recovered high white blood count (wbc) results when compared to an alternate instrument, with no instrument generated flags. Per the customer, the high wbc values occurred on some samples. Data was provided for six (6) patient samples to demonstrate this issue. Additionally, an erroneous high hemoglobin (hgb) result was observed on one (1) patient sample. The results provided by the customer are shown in the attachment section of this report. No erroneous results were reported out of the laboratory. The results obtained from the alternate instrument are considered correct and 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
[9029873]
Sample collection and storage information were not provided for this investigation. Controls are run daily and were run prior to the incident within assay range. However, the wbc parameter was high for the abnormal i level control after the incident. A field service engineer (fse) was dispatched and adjusted the wbc bath drain tubing on the wbc bath. The fse also ran twenty four (24) blood samples on the lh750, all of which matched results from the alternate instrument to verify system operation. The root cause is related to the adjustments made to the wbc bath during the instrument servicing subsequent to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00344 |
| MDR Report Key | 2075823 |
| Report Source | 06 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-04-05 |
| Date of Event | 2011-04-05 |
| Date Mfgr Received | 2011-04-05 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2012-03-28 |
| 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 | MA |
| 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 | 2011-05-03 |
| 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 | 2011-05-03 |