MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2013-05-21 for COULTER? PREPPLUS 2 PREP PLUS 2 378600 manufactured by Beckman Coulter.
[3511467]
(b)(4) distributor reported to beckman coulter (bec) that the flow count plated was not mixing on the coulter prepplus2 due to failure of the mixer motor. The failure has been detected by the biochemmack`s field service engineer (fse). The prepplus2 is used to prepare samples for analysis. The customer does not currently use flow count, therefore there were no incorrectly prepared samples. There were no erroneous results reported out of the laboratory. There was no death, injury, or effect to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[10845108]
The flow count is a bead suspension used in some flow cytometry applications to generate data used to calculating absolute counts for lymphocyte sub-sets. Flow count must be mixed well according to specific instructions to suspend the beads in solution. Failure of the flow count plate could result in erroneous absolute count results. A new mixer motor has been ordered and will be installed when it arrives. Cause of the problem was attributed to failure of the mixer motor. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-00915 |
| MDR Report Key | 3121487 |
| Report Source | 01,05,08 |
| Date Received | 2013-05-21 |
| Date of Report | 2013-04-25 |
| Date of Event | 2013-04-25 |
| Date Mfgr Received | 2013-04-25 |
| Device Manufacturer Date | 2012-09-03 |
| Date Added to Maude | 2013-07-29 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN CULTER |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? PREPPLUS 2 |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2013-05-21 |
| Model Number | PREP PLUS 2 |
| Catalog Number | 378600 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-21 |