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 2018-02-16 for ARCHITECT CEA 07K68-27 manufactured by Abbott Ireland.
[100466889]
Lot/serial number was not provided by the customer; therefore, only a partial udi is known an evaluation is in process. A follow up report will be submitted when the evaluation is complete. All available patient information was included.
Patient Sequence No: 1, Text Type: N, H10
[100466890]
The customer observed a falsely depressed carcinoembryonic antigen (cea) result on the architect i1000sr analyzer. The following data was provided: initial 55. 7 ng/ml, repeat 2. 6. There was no impact to the patient management of this (b)(6) male patient being treated for sigmoid colon cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00004 |
| MDR Report Key | 7278657 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-02-16 |
| Date of Report | 2018-03-16 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-02-16 |
| 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 | 2018-02-16 |
| Catalog Number | 07K68-27 |
| 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 | 2018-02-16 |