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 2018-10-24 for ARCHITECT CEA 07K68-35 manufactured by Abbott Ireland.
[126373364]
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
[126373365]
The customer observed poor reproducibility and falsely depressed results while using architect cea reagents. The following data was provided. Patient 1 sid (b)(6) repeat using analyzer sn (b)(4) 4. 9 iu/ml, initial value was higher using another analyzer (sn (b)(4)) 937 iu/ml. Patient 2 sid (b)(6) repeat using analyzer sn (b)(4) 0. 5 iu/ml, initial and repeat values were higher using another analyzer (sn (b)(4)) 5. 4, 5. 63 iu/ml. Patient 3 sid (b)(6) repeat using analyzer sn (b)(4) 0. 5 iu/ml, initial value was higher using another analyzer (sn (b)(4)) 4. 9 iu/ml. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008344661-2018-00091 |
| MDR Report Key | 8003074 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-24 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2018-10-24 |
| 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 | 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 | 2018-10-24 |
| Catalog Number | 07K68-35 |
| Lot Number | 86211FN00 |
| Device Expiration Date | 2019-09-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-10-24 |