MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-21 for COULTER TQ-PREP WORKSTATION N/A 6605429 manufactured by Beckman Coulter.
[60435561]
The customer found that the gravimetric test was failing. The customer replaced the syringe plunger assembly, which repaired the failing reagent tests. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[60435562]
The customer reported the coulter tq-prep workstation was failing the gravimetric test for reagent c. Erroneous results were not generated and there was no change or effect to patient treatment in connection with this event. Customer stopped using the instrument as soon as the problem was detected.
Patient Sequence No: 1, Text Type: D, B5
[62552091]
Since there were no erroneous results there is no risk of injury upon recur of this event and per current procedures this would not have been a reportable event. The date of event and the date of this report were corrected from (b)(6) 2016 to (b)(6) 2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2016-00976 |
| MDR Report Key | 6116375 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-21 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-11-23 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2016-11-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MIRANDA HOLLAND |
| Manufacturer Street | 11800 SW 147TH AVENUE, 32-S08 |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802031 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| 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 | AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO |
| Product Code | PER |
| Date Received | 2016-11-21 |
| Model Number | N/A |
| Catalog Number | 6605429 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-11-21 |