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 |