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 2017-07-25 for ADVIA CENTAUR XP CA 125II ASSAY N/A 10310443 manufactured by Siemens Healthcare Diagnostics, Inc..
[81068849]
A siemens field service engineer (fse) verified the instrument performance was acceptable. The technical application specialist (tas) tested the sample and the results were high. The sample was frozen and thawed between the initial test and the repeat test. It was not centrifuged after thawing. When the sample was again repeated, it recovered at 465 u/ml and 510 u/ml. The patient was redrawn and the new sample recovered 496 u/ml and 522 u/ml. The cause for the discordant ca 125ii result is unknown. Possible sample handling issue. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the dilutions section: "serum samples with ca 125 levels greater than 600 u/ml must be diluted and retested to obtain accurate results. " the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the ifu states in the limitations section: "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. "
Patient Sequence No: 1, Text Type: N, H10
[81068850]
A discordant low advia centaur xp ca 125ii result was obtained on a patient sample upon repeat at a later date. The patient sample was repeated after the customer changed the range from 0-320 to 2-600u/ml. The sample was tested initially and the value was >320. The patient sample was diluted and the result was higher. This result was reported to the physician and was not questioned. The sample was repeated again after thawing. The results were higher. A redraw sample was tested by the technical application specialist (tas) and the results were high. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant ca125ii result,
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00158 |
| MDR Report Key | 6739731 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-25 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-07-25 |
| 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 | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP CA 125II ASSAY |
| Generic Name | CA 125II IMMUNOASSAY |
| Product Code | LTK |
| Date Received | 2017-07-25 |
| Model Number | N/A |
| Catalog Number | 10310443 |
| Lot Number | 173 |
| Device Expiration Date | 2017-12-19 |
| Operator | OTHER HEALTH CARE 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 | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |