MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-04-13 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter Inc..
[18080026]
Bci field service engineer (fse) was dispatched on (b)(4) 201. Fse replaced tubing sample line from mixing chamber to flowcell, and stabilyse line tubing. Performance of the analyzer was verified. The root cause for the low event differential was associated with the incorrect volume of stabilyse entering the diff mixing chamber. This was caused by a hole/tear found in the stabilyse line tubing from the mixing chamber to the flowcell and the sample line.
Patient Sequence No: 1, Text Type: N, H10
[18375675]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh750 hematology analyzer generated erroneous low event differential flags. Testing of samples on an alternate instrument confirmed that low event differential results generated by the lh750 were incorrect. Results were not reported out of the lab. No reports of death, injury, or change to patient treatment have been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2011-00257 |
| MDR Report Key | 2055044 |
| Report Source | 01,06 |
| Date Received | 2011-04-13 |
| Date of Report | 2011-03-14 |
| Date of Event | 2011-03-14 |
| Date Mfgr Received | 2011-03-14 |
| Device Manufacturer Date | 2006-01-01 |
| 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 |
| 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 | 2011-04-13 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | N/A |
| ID 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 | 2011-04-13 |