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 2017-11-21 for ARCHITECT CA 125 II 02K45-23 manufactured by Abbott Laboratories.
[93471496]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[93471497]
The customer reports that on (b)(6) 2017, a female patient diagnosed with ovarian cancer generated an architect ca-125 assay result of 54. 2 u/ml (cut-off used by the customer is 35. 0 u/ml). The patient then underwent an ovariectomy. A post-surgical sample taken on (b)(6) 2017 generated a result of 62. 6 u/ml (heterophilic antibody treatment of this sample yielded a result of 20. 6 u/ml). On (b)(6) 2017 a result of 68 u/ml was obtained ((b)(6)). Heterophilic antibody treatment of this sample yielded a result of 14. 7 u/ml. On (b)(6) 2017, a sample from the lab's serum bank was obtained from this patient and was tested with a result of 74. 8 u/ml ((b)(6)). The sample from (b)(6) 2017 was sent to another lab and tested on the roche platform and generated a ca-125 assay result of 8. 1 u/ml (this method also has a cut-off value of 35 u/ml). There is no impact to patient management reported. Note: the architect ca-125 package insert warns the user: "ca 125 assay values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity. Prior to changing assays, the laboratory must confirm baseline values for patients being serially monitored. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2017-00206 |
| MDR Report Key | 7049298 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-11-21 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2017-02-01 |
| Date Added to Maude | 2017-11-21 |
| 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 | 2017-11-21 |
| Catalog Number | 02K45-23 |
| Lot Number | 72010M800 |
| Device Expiration Date | 2017-12-07 |
| 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 | 2017-11-21 |