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 2016-09-09 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter.
[54321421]
(b)(6). A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance. The fse, as part of troubleshooting, performed a high sensitivity system check which failed the foam portion due to high fliers. This led the fse to inspect the mixing system. The fse then replaced the mixer gripper spinners. Failing mixer gripper spinners can cause excessive splashing in the reaction vessels (rvs) which can lead to (b)(6) results in sandwich assays such as the access (b)(6) and access toxo igg assays. After completion of the repairs, the fse performed another high sensitivity system check which then passed within all published performance specifications. In conclusion, a hardware malfunction of the instrument's mixer gripper spinners in the cause of the (b)(6) results obtained by the customer.
Patient Sequence No: 1, Text Type: N, H10
[54321422]
The customer reported obtaining (b)(6) and toxoplasmosis gondii igg (access toxo igg) results for an unknown number of patients on the laboratory's unicel dxi 800 access immunoassay system serial number (b)(4). One example of a (b)(6) access toxo igg result was provided. This patient's sample was initially analyzed on the unicel dxi 800 access immunoassay system serial number (b)(4) and a (b)(6) result was obtained. The same sample was then analyzed on an alternate methodology from abbott (exact method was not provided) and a (b)(6) result was obtained. The (b)(6) access (b)(6) and access toxo igg results were not released from the laboratory. There was no report of change to or impact to patient treatment in conjunction with this event. Assay calibrations were passing within assay specifications prior to the event. The customer did not provide qc (quality control) or other performance indicators for review. The customer did not supply any information regarding sample collection or sample processing (including centrifugation information) for this event. There were no reports of issues with sample integrity in conjunction with this event. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2016-00442 |
| MDR Report Key | 5939450 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-09 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-08-16 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2016-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681330 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LKQ |
| Date Received | 2016-09-09 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Brand Name | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JJE |
| Date Received | 2016-09-09 |
| Model Number | NA |
| Catalog Number | 973100 |
| 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 | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-09 |