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 2016-11-13 for ARCHITECT CA 125 II 02K45-28 manufactured by Abbott Laboratories.
[59764574]
An evaluation is in process. A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[59764575]
The account generated a falsely depressed architect ca125 ii of 4. 6 u/ml on a patient which did not match previous history of around 1900 u/ml. The sample was repeated with architect ca125 ii of about 1900 u/ml. No specific patient information was provided. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[63223997]
A review of ticket trending data for the architect ca 125 ii assay was performed. The review did not identify any adverse trends or non-statistical trends that indicate a product issue related to patient results. A lot search was not performed since the lot number is unknown. Since the likely cause lot number is unknown, historic accuracy testing was reviewed. This testing was completed to evaluate the assay performance of lot 50283m500. The testing met acceptance criteria. Labeling was also reviewed and adequately addresses the complaint issue. Based on this evaluation, the architect ca125 ii assay is performing as expected.
Patient Sequence No: 1, Text Type: N, H10
[75437476]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site. However, no systemic issue and/or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00108 |
| MDR Report Key | 6098334 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-11-13 |
| Date of Report | 2017-05-09 |
| Date Mfgr Received | 2017-04-17 |
| Date Added to Maude | 2016-11-13 |
| 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 LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT CA 125 II |
| Generic Name | OC 125 DEFINED ANTIGEN |
| Product Code | LTK |
| Date Received | 2016-11-13 |
| Catalog Number | 02K45-28 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-13 |