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 2014-08-19 for TQ-PREP WORKSTATION 6605429 manufactured by Beckman Coulter.
[4877167]
The customer reported low dispensing volume on the first tube prepped when using the tq-prep workstation. The tq-prep was delivering low volumes of reagents a (lyse) and b (quench) on the first tube prepped after powering up the unit. A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the system. There were no erroneous test results with this event. There was no death, injury or affect to user or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[12342676]
(b)(6). On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the system and replaced the syringes delivering reagents a and b in the instrument resolving the problem. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2014-01984 |
| MDR Report Key | 4021681 |
| Report Source | 01,05,06 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-24 |
| Date Mfgr Received | 2014-07-24 |
| Device Manufacturer Date | 2011-03-15 |
| Date Added to Maude | 2014-09-03 |
| 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 BLVD |
| 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 | TQ-PREP WORKSTATION |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2014-08-19 |
| Model Number | NA |
| Catalog Number | 6605429 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION: 1.1 |
| 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 | 2014-08-19 |