MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-13 for UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2729484]
The customer provided additional information in regards to a previously submitted medical device report (2122870-2012-00878) which involved the generation of multiple erroneous patient results from a unicel dxl800 access immunoassay system. One of the erroneous patient results involved in the event was an erroneously elevated thyroglobulin result. The erroneous thyroglobulin result was reported out of the laboratory and the patient underwent unnecessary surgery based upon the erroneous result. The details and impact of this surgery on the patient are currently unknown. Repeat thyroglobulin testing did not match the original result obtained. Quality control results were recovering with the customer's established specifications during the timeframe of this event. No patient specific information, actual patient results, system assay performance information or sample collection/handling information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[9925701]
(b)(6). Service was dispatched to the site on (b)(4) 2012 for this event. The field service engineer (fse) cleaned the analytical module and replaced the gripper mixers and peri-pump tubing. The fse also replaced the sample probe and wash nozzle due to a failed carryover test. The fse reviewed the customer's event log and errors. Based upon this review the fse indicated that it is possible that the instrument experienced a probe crash, however, this was not confirmed. Upon completion of the necessary and verified repairs, the instrument was returned back into operation. A definitive root cause has not been determined to date for this event. Mdrs associated with this event: 2122870-2012-01471, 2122870-2012-00878.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01471 |
| MDR Report Key | 2615319 |
| Report Source | 05,06 |
| Date Received | 2012-06-13 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-03-05 |
| Date Mfgr Received | 2012-05-22 |
| Device Manufacturer Date | 2008-07-31 |
| Date Added to Maude | 2012-06-14 |
| 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 |
| 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, INC |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JNL |
| Date Received | 2012-06-13 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID 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, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-06-13 |