MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-23 for COULTER? PREPPLUS 2 PREP PLUS 2 378600 manufactured by Beckman Coulter, Inc..
[17063590]
A customer stated that the coulter prepplus 2 system did not alert upon aspirating from an empty reagent vial. The issue was discovered upon review of the results from the fc500 analyzer. No erroneous results were reported outside of the lab. There were no reports of death, injury or effect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[17316659]
Data was requested but not provided for the investigation. The customer stated that the cd45-ecd and cd7pe reagents were not added to the sample that was run on the cf 500 instrument. Beckman coulter instructs the operator to "check that each reagent container contains at least the volume listed on the work-list (plus an additional 10% of the full volume of the container to account for dead volume). " the instrument is currently performing within qc specifications with respect to controls and reproducibility. Service verified repair per established procedures; results meet published performance specifications. System validation is documented in customer qc record.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00164 |
| MDR Report Key | 2028060 |
| Report Source | 07 |
| Date Received | 2011-03-23 |
| Date of Report | 2011-02-22 |
| Date of Event | 2011-02-22 |
| Date Mfgr Received | 2011-02-22 |
| Device Manufacturer Date | 2006-03-01 |
| 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 BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN CULTER 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? PREPPLUS 2 |
| Generic Name | MICROPROCESSOR-CONTROLLED PIPETTING AND DILUTING SYSTEM |
| Product Code | LOQ |
| Date Received | 2011-03-23 |
| Model Number | PREP PLUS 2 |
| Catalog Number | 378600 |
| 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 | 2011-03-23 |