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 2014-09-09 for COULTER DXH DILUENT 628017 manufactured by Beckman Coulter.
[21971585]
The customer reported obtaining platelet (plt) background failures and nucleated red blood cell (nrbc) interference flags from the unicel dxh 800 coulter cellular analysis system while using the coulter dxh diluent lot number 3510540. Erroneous patient 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
[22210425]
A field service engineer (fse) was dispatched to the customer's site. The fse performed troubleshooting on the unicel dxh 800 coulter cellular analysis system but the issue was not resolved. The fse then replaced the coulter dxh diluent reagent lot #3510540 with a dxh diluent reagent lot #016114k and no further issues were noted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2014-02299 |
| MDR Report Key | 4076076 |
| Report Source | 01,05,06 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-08-14 |
| Date of Event | 2014-08-14 |
| Date Mfgr Received | 2014-08-14 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2014-09-23 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-08/25/2014-003C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER DXH DILUENT |
| Generic Name | DILUENT, BLOOD CELL |
| Product Code | GIF |
| Date Received | 2014-09-09 |
| Model Number | NA |
| Catalog Number | 628017 |
| Lot Number | 3510540 |
| Device Expiration Date | 2015-12-22 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-09-09 |