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 2017-07-12 for ARCHITECT CA 125 II 02K45-28 manufactured by Abbott Laboratories.
[80073641]
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
[80073642]
The customer reports the following architect ca125 ii assay results generated on an architect i2000sr analyzer (units of measure are u/ml): sid (b)(6) ca125 initial reported result 6, amended result 17; sid (b)(6) ca125 initial reported result less than 1. 0, amended result 13 ; sid (b)(6) ca125 initial reported result 2. 0, amended result 12. The initial results are considered incorrect by the customer and were reported from the lab. The amended results were subsequently reported and considered correct. The customer observed general imprecision with this assay. Quality control samples were within specifications. Assay testing at this site is performed to monitor patients' response to therapy to epithelial ovarian cancer. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2017-00160 |
| MDR Report Key | 6707430 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-27 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2017-07-12 |
| 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 | 2017-07-12 |
| Catalog Number | 02K45-28 |
| Lot Number | 70006M800 |
| Device Expiration Date | 2017-10-21 |
| 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 | 2017-07-12 |