MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-13 for ADVIA CENTAUR XP CA 125II IMMUNOASSAY N/A 10310443 manufactured by Siemens Healthcare Diagnostics, Inc..
[87219194]
The cause for the discordant ca 125ii results is unknown. The original samples were stored refrigerated and not frozen until testing. The instructions for use states that the samples must be frozen within 24 hours. A siemens field service engineer (fse) went on site and found reagent probes 1 and 3 were bent and out of alignment. The probes were replaced. The customer ran additional patients and observed the following results; (b)(6). A decontamination of the both systems in the customer's lab was performed. (b)(6). Siemens continues to investigate. The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the limitations section of the instructions for use states: "note: do not interpret levels of ca 125 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed ovarian carcinoma frequently have levels of ca 125 within the range observed in healthy individuals. Elevated levels of ca 125 can be observed in patients with nonmalignant diseases. Measurements of ca 125 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. The concentration of ca 125 in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity. Ca 125 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. The concentration of ca 125 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity. Ca 125 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. Therefore, it is important to use assay specific values to evaluate quality control results. " mdr 1219913-2017-00191 for patients 1 and 3 was filed for different patients from the same complaint on a different day.
Patient Sequence No: 1, Text Type: N, H10
[87219195]
During a comparison study with a new lot of advia centaur xp ca 125ii, the customer noted a difference in patient sample results for two samples. There are no reports that treatment was altered or prescribed or adverse health consequences due to the difference in advia centaur xp ca 125ii results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00202 |
| MDR Report Key | 6861306 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-13 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-08-16 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2017-09-13 |
| 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 | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CA 125II IMMUNOASSAY |
| Generic Name | CA 125II IMMUNOASSAY |
| Product Code | LTK |
| Date Received | 2017-09-13 |
| Model Number | N/A |
| Catalog Number | 10310443 |
| Lot Number | 22096173 |
| Device Expiration Date | 2017-12-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-13 |