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 2018-01-18 for ARCHITECT CA 125 II 02K45-28 manufactured by Abbott Laboratories.
[97989337]
This issue was previously reported under mdr number 1628664-2017-00528. Under a different suspect medical device. The suspect medical device was changed on (b)(6) 2017 upon further investigation of the customer issue. The customer's instrument logs were reviewed for the samples tested in (b)(6) 2017. This review did not identify conclusive information to indicate an instrument or sample integrity issue occurred. Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue. Complaint searches determined that there is normal complaint activity for the likely cause lot. Labeling was reviewed and found to be adequate. Manufacturing documentation review (or equivalent) of the affected instrument serial number has been reviewed and no contributing factors to the complaint could be identified. Accuracy testing was also performed to evaluate the performance of reagent lot 77015m800. An internal ca 125 ii panel was tested with retained kits of the likely cause reagent lot. Acceptance criteria were met, which indicates acceptable product performance. Based on the available information, no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[97989338]
The customer stated that a falsely decreased architect ca-125 result of <1. 0 u/ml was generated for patient sample (b)(6) on (b)(6) 2017. No error messages were generated. The same sample was automatically retested twice and the results were 24. 3 and 25. 4 u/ml. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00003 |
| MDR Report Key | 7203516 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-01-18 |
| Date of Report | 2018-01-18 |
| Date of Event | 2017-12-08 |
| Date Mfgr Received | 2017-12-28 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-01-18 |
| 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 |
| 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 | 2018-01-18 |
| Catalog Number | 02K45-28 |
| Lot Number | 77015M800 |
| Device Expiration Date | 2018-06-02 |
| 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 | 2018-01-18 |