MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-06 for ADVIA CENTAUR XP CA 125II ASSAY N/A 10315696 manufactured by Siemens Healthcare Diagnostics, Inc..
[64064158]
The cause for the discordant ca 125ii result is unknown. Siemens healthcare diagnostics is investigating. 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
[64064159]
A discordant low advia centaur xp ca 125ii result was obtained on a patient sample. The patient sample was tested on an alternate method and an interferent error was obtained. The patient sample was diluted and tested on the alternate method. The result was high. The diluted sample was then retested on the advia centaur xp ca 125ii and the result was high. The patient was tested previously in (b)(6) and the diluted result was high. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant ca 125ii result.
Patient Sequence No: 1, Text Type: D, B5
[73690368]
Siemens filed the initial mdr 1219913-2016-00260 on january 6, 2017. On 03/22/2017 correction: the kit lot number of the initial mdr was incorrect. The correct kit lot # is 03808170 and the expiration date is 3/31/2017. (b)(4). On 3/22/2017 additional information: the customer sent two samples for further testing and investigation. The samples were tested with advia centaur xp ca 125ii reagent lot 051172. Results: sample (b)(6): neat replicate 1: >600, neat replicate 2: >600, dilution 1:100 replicate 1: 51,510, dilution 1:100 replicate 2: 52,920, dilution 1:100 replicate 3: 48,830. Sample (b)(6): neat replicate 1: >600, neat replicate 2: >600, dilution 1:100 replicate 1: >600, dilution 1:100 replicate 2: >600, dilution 1:100 replicate 3: >600. Siemens was not able to to confirm the customer observation of values <600 u/ml with advia centaur xp ca 125ii reagent lot 051170. The testing was performed with reagent lot 05172 and results obtained were > 600 u/ml neat and > 50,000 u/ml when diluted 1:100. The cause for the discordant advia centaur xp ca 125ii result is unknown. There may have been a shipping/handling issue with the customer's reagents. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00260 |
| MDR Report Key | 6229173 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-06 |
| Date of Report | 2017-04-05 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-01-06 |
| 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 | 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 |
| Remedial Action | IN |
| 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 | 2017-01-06 |
| Model Number | N/A |
| Catalog Number | 10315696 |
| Lot Number | 42045171 |
| Device Expiration Date | 2017-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-01-06 |