MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-09-18 for COULTER TQ-PREP WORKSTATION 6605429 manufactured by Beckman Coulter.
[26207542]
The customer observed that the sample tube did not have the correct amount of reagent when the sample was prep on the tq prep instrument. The sample line had aspirated air since the reagent bottles were empty. There was a failure of the sensors. No error message alerted the customer that the reagent bottles were empty since the sensors had failed. The fse replaced both reagent sensors to resolve the issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26207543]
The fse (field service engineer) reported that the reagent sensors (reagent a and reagent b sensors) in a coulter tq-prep workstation failed and did not generate the low reagents messages. The customer performs the daily instrument check as per instructions for use and the customer visually confirms the tubes after preparation, which alerted the customer to the issue. Erroneous results were not generated and there was no change or effect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2015-01480 |
| MDR Report Key | 5088649 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-18 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-09-02 |
| Date Mfgr Received | 2015-09-02 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-09-18 |
| 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 | 2015-09-18 |
| Model Number | NA |
| Catalog Number | 6605429 |
| Lot 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 | 2015-09-18 |