MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-17 for COULTER LH 755 ANALYZER 6605732 manufactured by Beckman Coulter, Inc..
[1953999]
A customer contacted beckman coulter inc. (bci) stating that the coulter lh 755 analyzer gave erroneously high retic results on a specific specimen without instrument generated retic flag, but gave a nucleated red blood count (nrbc) instrument generated message for the differential. The results were reported out of the laboratory; however, a manual retic count recovered lower. There was no death, injury, or change to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9223720]
Controls were run before and after the incident and recovered within assay limits. The instrument is currently within qc specifications with respect to controls and reproducibility. According to the raw data analysis, the pattern does not detect any abnormal data pattern as ir is not seen as possessing any interference that would be suspected to affect the reticulocytes percentage. A field service engineer (fse) was dispatched and replaced the retic pak level. Per product labeling: beckman coulter inc. Does not claim to identify every abnormality in all samples. Beckman coulter inc. Suggests using all available flagging options to optimize the sensitivity of instrument results based on your patient population. All flagging options include reference ranges (h/l), action and critical limits, definitive flags, suspect flags, parameter codes, delta checks, decision rules and system alarms. Beckman coulter inc. Recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions. The lh 700 series applies instrument-generated and/or laboratory-defined flags, codes, and/or messages to each set of patient results. Flags, codes, suspect and definitive messages are used to alert you to an instrument malfunction, specimen abnormality, abnormal data pattern, or abnormal results. Beckman coulter recommends review, appropriate to your patient population, of all results displaying a flag, code or other message.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00149 |
| MDR Report Key | 2021274 |
| Report Source | 06 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-02-10 |
| Date Mfgr Received | 2011-02-14 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2012-02-15 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 755 ANALYZER |
| Generic Name | AUTOMATED DIFFERENTIAL CELL COUNTER |
| Product Code | LOQ |
| Date Received | 2011-03-17 |
| Model Number | LH 755 |
| Catalog Number | 6605732 |
| 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 | 2011-03-17 |