MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-28 for COULTER LH 750 ANALYZER 6605632 manufactured by Beckman Coulter, Inc..
[1946277]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 750 analyzer gave erroneous differential results on a specimen without instrument generated messages from one patient. Manual review showed one (1) blast. Erroneous results were not reported out of the laboratory. There was no death, injury or change to patient treatment as a result of this incident. There was no change to patient treatment as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[9048205]
Specimen was collected in a 5 cc vacutainer tube and sampled <2 hours after collection. Controls were run before and after the incident and recovered within assay ranges. The instrument is currently performing within qc specifications with respect to controls (accuracy and precision). Service was not dispatched for this event. The root cause, based on raw data analysis, for the erroneous differential results and the false negative blast flagging is that the algorithm could not set suspect flags because there are no significantly abnormal patterns on the histograms. Per product labeling, beckman coulter inc. Does not claim to identify every abnormality in all samples.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00324 |
| MDR Report Key | 2072359 |
| Report Source | 06 |
| Date Received | 2011-04-28 |
| Date of Report | 2011-03-29 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-03-29 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2012-03-26 |
| 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 |
| 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 | 2011-04-28 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-04-28 |