MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-22 for ACCESS CEA 33200 manufactured by Beckman Coulter.
[103184888]
The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race. The access cea reagent was not returned for evaluation. All assay and system verifications (calibration, quality control, system check) met specifications at the time of this event. No hardware errors, flags or other assay issues were reported in conjunction with this event. Conclusion: the cause of the elevated access cea result cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[103184889]
The customer reported obtaining an elevated carcinoembryonic antigen (access cea) result for one patient involving the laboratory's access 2 immunoassay system portion to their unicel dxc 600i synchron access clinical system (serial number (b)(4)). The result was reported out of the laboratory. Due to the elevated result, the patient had a cat scan and a colonoscopy. The customer reported that the results were negative. There was no report of additional change to treatment. Approximately one month later another sample was collected from the patient and analyzed two times on the same access 2 immunoassay system portion to their unicel dxc 600i synchron access clinical system. This sample recovered with lower access cea results. Quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event. There were no hardware errors or other assay issues reported in conjunction with this event. The samples were collected in serum tubes and centrifuged at 3150 revolutions per minute (rpm) for ten minutes at room temperature. No issues with sample integrity were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2018-00021 |
| MDR Report Key | 7362004 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-22 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2017-10-09 |
| Date Added to Maude | 2018-03-22 |
| 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 | 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 | ACCESS CEA |
| Generic Name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Product Code | DHX |
| Date Received | 2018-03-22 |
| Model Number | NA |
| Catalog Number | 33200 |
| Lot Number | 795018 |
| Device Expiration Date | 2018-10-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2018-03-22 |