MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-03 for COULTER DXH DILUENT 628017 manufactured by Beckman Coulter.
[21721934]
The customer reported platelet background high failures on two unicel dxh 800 coulter cellular analysis systems in the customer's laboratory when using a specific lot number of coulter dxh diluent. 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
[22146909]
Customer states instruments were removed from service when high backgrounds occurred and was not placed back into service until the issue was resolved. The customer technical specialist ordered replacement reagent per customer request. The unicel dxh 800 coulter cellular analysis system serial number (b)(4) is associated with this event. (b)(4). This mdr is related to mdr 1061932-2014-02187 for the other unicel dxh 800 coulter cellular analysis system serial number (b)(4) in the customer's facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2014-02188 |
| MDR Report Key | 4056416 |
| Report Source | 05,06 |
| Date Received | 2014-09-03 |
| Date of Report | 2014-08-08 |
| Date of Event | 2014-08-08 |
| Date Mfgr Received | 2014-08-08 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2014-09-17 |
| 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 |
| 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 | BLOOD CELL DILUENT |
| Product Code | GIF |
| Date Received | 2014-09-03 |
| 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 | 2014-09-03 |