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 2014-08-13 for COULTER TQ-PREP WORKSTATION 6605429 manufactured by Beckman Coulter.
[4958750]
The customer reported that coulter immunoprep reagent b (whole blood lysing solution) was not being delivered into the sample tubes of the coulter tq-prep workstation. Erroneous results were not generated and there was no change or affect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[11933549]
A field service engineer (fse) was dispatched to the customer's site. The fse evaluated the instrument and discovered the syringe motor to reagent b was not moving and was defective. The fse replaced the syringe motor assembly, performed verification tests, and verified that the instrument was operational. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2014-01924 |
| MDR Report Key | 4007224 |
| Report Source | 01,05,06 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-07-17 |
| Date Mfgr Received | 2014-07-18 |
| Device Manufacturer Date | 2013-01-15 |
| Date Added to Maude | 2014-08-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 TQ-PREP WORKSTATION |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2014-08-13 |
| Model Number | NA |
| Catalog Number | 6605429 |
| Lot Number | NA |
| ID Number | SW VERSION 2.04 |
| 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 | 2014-08-13 |