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 2019-04-03 for ARCHITECT CA 125 II 02K45-28 manufactured by Abbott Laboratories.
[140798881]
Review of complaint activity did not identify any adverse or non-statistical trends for the architect ca 19-9xr assay. An increase in complaint activity was not identified for falsely elevated results with reagent lot 88032m800. The customer's instrument logs were reviewed. This review did not identify conclusive information to indicate an instrument or sample integrity issue occurred while processing the initial result. Using world wide field data the historical performance of reagent lot 88032m800 was evaluated. The patient data was analyzed and compared to an established control limit. This evaluation indicated that the patient median result for the lot was within the established control limits. Therefore, no unusual reagent lot performance was identified. Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue. Additionally, labeling was reviewed and sufficiently addresses the customer's issue. No systemic issue or deficiency of the architect ca 19-9xr assay was identified. Patient identifier: complete entry is (b)(6) section a. Patient information: no further patient information was provided.
Patient Sequence No: 1, Text Type: N, H10
[140798882]
The customer reported a false elevated ca125 result when processing on the architect i1000sr. Sample id (b)(6) generated an initial result was 591. 0 u/ml. At an alternate lab the patient received results of 5. 0 and 6. 0 u/ml on cmia method (assay unknown). The customer recollected the sample and the results were 6. 1 and 6. 2 u/ml. Using a different lot, the following results were generated: 6. 1, 5. 7, 5. 6 and 6. 0 u/ml. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2019-00021 |
| MDR Report Key | 8479235 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-04-03 |
| 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 | 2019-04-03 |
| Catalog Number | 02K45-28 |
| Lot Number | 88032M800 |
| Device Expiration Date | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-04-03 |