MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-12-01 for ARCHITECT CEA 07K68-32 manufactured by Abbott Ireland.
[94637404]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[94637405]
The customer observed inconsistent carcinoembryonic antigen (cea) results while using the architect cea reagents. The following data was provided for the same patient. The customer uses reference range 0 to 5 ng/ml. Sid (b)(6) (tested (b)(6) 2017) 20, repeat at another facility using the abbott method 2. 79 sid (b)(6) was tested (b)(6) 2017 and the result was 2. 51. The patient had been previously diagnosed with gastric cancer, and tests were being done postoperatively (gastric cancer resection). No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2017-00098 |
| MDR Report Key | 7075947 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-12-01 |
| Date of Report | 2018-02-14 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2018-02-14 |
| Date Added to Maude | 2017-12-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT IRELAND |
| Manufacturer Street | DIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK |
| Manufacturer City | SLIGO NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT CEA |
| Generic Name | CARCINOEMBRYONIC ANTIGEN |
| Product Code | DHX |
| Date Received | 2017-12-01 |
| Catalog Number | 07K68-32 |
| Lot Number | 76020FN00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT IRELAND |
| Manufacturer Address | DIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK SLIGO NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-01 |