MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for ARCHITECT CA 125 II 02K45-28 manufactured by Abbott Laboratories.
[134982822]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There is no further patient information provided due to privacy issues.
Patient Sequence No: 1, Text Type: N, H10
[134982823]
The customer reported falsely elevated architect ca 125 results on one patient. The results provided were: (b)(6) 2019 on serial number (b)(4) = 53. 4u/ml / on sn (b)(4) = 14. 3u/ml; repeated on (b)(6) 2019, sn (b)(4) = 55. 2u/ml / on (b)(6) 2019, sn (b)(4) = 51. 6u/ml; second sample drawn tested on (b)(4) = 42. 1u/ml / (b)(4) = 25. 9u/ml; on another architect analyzer at a different site = 28u/ml. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2019-00034 |
| MDR Report Key | 8293658 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2018-09-01 |
| Date Added to Maude | 2019-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 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 | 2019-01-31 |
| Catalog Number | 02K45-28 |
| Lot Number | 91010M800 |
| Device Expiration Date | 2019-07-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-31 |