MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-26 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1960256]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer generated an erroneously low platelet (plt) result that was reported out of the laboratory. There was no death, injury, or affect to patient treatment reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[9091488]
The specimens were collected in edta vacutainers. The instrument is currently within qc specifications with respect to controls and reproducibility. The controls are run once per shift. Patient controls are also run throughout each shift. Controls were run before and after the incident and recovered within range. A field service engineer (fse) was dispatched on (b)(4) 2011 and bleached the red blood count (rbc) / platelet (plt) apertures and ran the latex/flow rate matching procedure with no issues. The fse also ran all verifications which all passed successfully. Per the customer, the instrument is operating adequately since the service visit and that the lab is doing manual smear on plt counts under 150.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00195 |
| MDR Report Key | 2030098 |
| Report Source | 06 |
| Date Received | 2011-03-26 |
| Date of Report | 2011-02-24 |
| Date of Event | 2011-02-24 |
| Date Mfgr Received | 2011-02-24 |
| Device Manufacturer Date | 2006-03-01 |
| 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 | RP |
| 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 | 2011-03-26 |
| 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 | 2011-03-26 |