MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-10 for COULTER? PREPPLUS 2 CYTOMERTY PREP PLUS 2 378600 manufactured by Beckman Coulter Inc..
[20630238]
A customer contacted beckman coulter inc. (bci) and report the small reagent rack position is not alerting when vial reagents are empty. Patient results could have been erroneous the erroneous results were not reported outside of the lab. Data showed that tubes prepped with the instrument had no positive peak and repeat run had a positive peak as expected. No reports of death, injury or affect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[20814067]
Control information prior to and after the event was not provided. Sample information was not provided for this event. Service call was generated. Service discussed pca with customer ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00101 |
| MDR Report Key | 2015299 |
| Report Source | 06 |
| Date Received | 2011-03-10 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-02-12 |
| Date Mfgr Received | 2011-02-14 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2012-02-08 |
| 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 BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613436 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33916 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33916 |
| Single Use | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-01/24/2011-002C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? PREPPLUS 2 CYTOMERTY |
| Generic Name | COULTER? PREPPLUS 2 |
| Product Code | LOQ |
| Date Received | 2011-03-10 |
| Model Number | PREP PLUS 2 |
| Catalog Number | 378600 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33916 US 33916 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-10 |