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 2017-09-19 for ARCHITECT CA 125 II 02K45-28 manufactured by Abbott Laboratories.
[87340878]
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, labeling review, and field data review. No adverse trend was identified for the customer issue. Device history review did not identify any issues that may have caused the customer issue. Labeling was reviewed and found to be adequate. The product was not available for return. Review of field data showed the complaint lot patient median value was within the range of other lots in the field between september 11, 2016 and september 9, 2017. No unusual reagent lot performance was identified. Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found. This issue was previously submitted under mdr number 3002809144-2017-00121. This report is being submitted to document the correct manufacturer that was incorrect in mdr number 3002809144-2017-00121.
Patient Sequence No: 1, Text Type: N, H10
[87340879]
The customer observed falsely elevated ca125 results while using the architect ca125 reagents. The following data was provided (u/ml). Ca125 3500 u/ml, result from last month 9800 u/ml. The patient had previously undergone surgery for ovarian cancer and was undergoing chemotherapy. Tests were performed for follow up observation of the patient. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2017-00181 |
| MDR Report Key | 6877701 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-09-19 |
| Date of Report | 2017-09-19 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2017-09-19 |
| 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 | 2017-09-19 |
| Catalog Number | 02K45-28 |
| Device Expiration Date | 2017-08-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-09-19 |