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 2018-04-12 for ARCHITECT CEA 07K68-35 manufactured by Abbott Ireland.
[105400148]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. An evaluation is in-process.
Patient Sequence No: 1, Text Type: N, H10
[105400149]
The customer observed erratic results while using the architect cea assay. The customer provided the following results data: on (b)(6) 2018 cea initial 0. 5, retest 4. 4 ng/ml there was no impact to patient management reported. No additional patient information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00030 |
| MDR Report Key | 7426437 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-04-12 |
| Date of Report | 2018-08-24 |
| Date of Event | 2018-01-02 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-04-12 |
| 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 | 2018-04-12 |
| Catalog Number | 07K68-35 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-12 |