MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-03-13 for COULTER? PREPPLUS2 PREP PLUS 2 378600 manufactured by Beckman Coulter Inc..
[2631448]
A customer contacted beckman coulter inc (bec) stating that two coulter prepplus2 instruments were demonstrating level sense issues where flow count reagent was not being aspirated. The customer stated that both of the instruments had flow count aspiration issues and that occasionally their probes were stopping outside the flow count bottle and aspirating air instead. No erroneous results were reported outside the laboratory. The samples were analyzed on the customer's coulter fc500 instrument and the samples were invalidated during the sample analysis run. There was no affect to patients. This report documents the second prep plus 2 instrument (serial number (b)(4)) which was a loaner instrument from bec to the customer (while the primary unit was returned to bec for servicing). Per customer, this unit also had problems detecting blood in specimen tube in addition to flow count detection. Prepplus2 serial number (b)(4) which was demonstrating level sense issues where flow count reagent was not being aspirated has been documented in a separate mdr report (1061932-2012-00874).
Patient Sequence No: 1, Text Type: D, B5
[9753230]
The customer stated that controls were run before and after the incident with passing results. Data provided showed an erroneous result for lymph count and its subsets (cd19, cd8, cd4, and cd3) but was not reported outside the laboratory. A field service engineer (fse) went on-site and found no aspiration problem on the returned unit (serial number (b)(4)) only that the screw was too short at level of insulator box. The short screw did not contribute to the reported event. This unit was later returned to the customer and they have since not had any flow count problems. The occasional level sense issue in both instruments and the blood detection issue for the loaner instrument are unknown and are currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-00875 |
| MDR Report Key | 2490460 |
| Report Source | 01,05,06 |
| Date Received | 2012-03-13 |
| Date of Report | 2012-02-29 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2012-02-29 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2012-08-29 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? PREPPLUS2 |
| Generic Name | PIPETTING AND DILUTING SYSTEM FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2012-03-13 |
| Model Number | PREP PLUS 2 |
| Catalog Number | 378600 |
| Lot Number | NA |
| ID Number | SW VERSION 2.03 |
| 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 | 2012-03-13 |