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 2018-12-13 for DXI (CLSI) CONNECTION, POWER EXPRESS B36348 manufactured by Beckman Coulter.
[131381609]
Beckman coulter complaint handling unit evaluated the issue with the power express. The power express needs a serial connection from instruments and in this case there was a triple connection from the access immunoassay dxi system. The failure mode was identified as an error in the connection of the cables when the communications module was changed. The connection of the cables was corrected to resolve the issue. (b)(6). The beckman coulter internal identifier is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131381610]
The customer reported obtaining multiple erroneous patient results on their unicel dxi 800 access immunoassay system. The customer reported several erroneous results on multiple assays including vitamin b12. Due to an error in the connection of 2 dxi to pex (power express), the results obtained by these analyzers on (b)(6) 2018 were erroneously assigned to a wrong id (identification). Only samples processed by pex were affected. The customer identified 136 samples that were affected with discrepant results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2018-01042 |
| MDR Report Key | 8162788 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-14 |
| Date Facility Aware | 2018-11-16 |
| Date Mfgr Received | 2018-11-16 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-12-13 |
| 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 | MR DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 928218000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXI (CLSI) CONNECTION, POWER EXPRESS |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2018-12-13 |
| Model Number | DXI (CLSI) CONNECTION, POWER EXPRESS |
| Catalog Number | B36348 |
| 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 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-13 |