MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for ARCHITECT CEA 07K68-27 manufactured by Abbott Ireland.
[77735326]
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
[77735327]
The customer reported they obtained a false depressed result on the architect cea assay with reagent lot 72324fn00. Sample id (b)(6) generated an initial result of 3. 35 ng/ml and when repeated in duplicate (sample id (b)(6)) generated 149. 00 and 142. 16 ng/ml.
Patient Sequence No: 1, Text Type: D, B5
[96236997]
Update: patient and device codes were provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008344661-2017-00057 |
| MDR Report Key | 6645040 |
| Date Received | 2017-06-15 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-07-07 |
| Device Manufacturer Date | 2017-02-10 |
| Date Added to Maude | 2017-06-15 |
| 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 | 2017-06-15 |
| Catalog Number | 07K68-27 |
| Lot Number | 72324FN00 |
| Device Expiration Date | 2018-07-23 |
| 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 | 2017-06-15 |