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 2019-02-13 for ARCHITECT CA 125 II 02K45-28 manufactured by Abbott Laboratories.
[139237627]
A review of tickets for lot 91010m800 did not identify an increase in complaint activity related to the complaint issue and there were no trends found for the issue. Return testing was not completed as returns were not available. Historical performance of reagent lot 91010m800 was evaluated using world wide data from abbottlink. The patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for lot 91010m800 is within the established control limits. Therefore, no unusual reagent lot performance was identified for lot 91010m800. A review of the manufacturing documentation did not identify any issues associated with the customer's observation. A review of labeling concluded that the issue is adequately addressed. Based on the investigation no product deficiency was identified for architect ca 125 ii, reagent lot 91010m800. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139237628]
The customer reported falsely elevated architect ca 125 results on one patient. The results provided were: on (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 | 1415939-2019-00008 |
| MDR Report Key | 8337328 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-09-01 |
| Date Added to Maude | 2019-02-13 |
| 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 | 2019-02-13 |
| Catalog Number | 02K45-28 |
| Lot Number | 91010M800 |
| Device Expiration Date | 2019-07-26 |
| 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 | 2019-02-13 |