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 2016-03-18 for ADVIA CENTAUR XPT CA 15-3 ASSAY N/A 10327620 manufactured by Siemens Healthcare Diagnostics, Inc..
[40728058]
The customer suspected the reagent readypack due to extremely low quality control and patient results. The customer stores some of their readypacks in closed boxes when in the refrigerator. The refrigerator where the readypacks are stored has glass doors and sometimes the internal light below the readypacks was left on. The customer cannot say whether the boxes are close to the light. Siemens healthcare diagnostics recommended to the customer to store ca15-3 reagent kits as far away from the light as possible. The cause for the discordant advia centaur xpt ca15-3 results is unknown. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the storing and stability section: "store the reagents upright at 2-8? C. Protect reagent packs from all heat and light sources. Reagent packs loaded on the system are protected from light. Store unused reagent packs at 2-8? C away from heat and light sources. All reagents are stable at 2-8? C until the expiration date on the packaging. " the ifu states in the limitation section: "note: do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals. Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases. Measurements of ca 15-3 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. " note: product availability may vary from country to country and is subject to varying regulatory requirements. Due to local regulations, the advia centaur xpt is not available in all countries.
Patient Sequence No: 1, Text Type: N, H10
[40728059]
Discordant advia centaur xpt ca 15-3 results were obtained for samples from two patients. The initial results were low. The customer suspected the reagent readypack was defective. The patient samples were repeated on another instrument with a different reagent readypack. The repeat results were high. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant ca 15-3 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2016-00056 |
| MDR Report Key | 5512152 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-18 |
| Date of Report | 2016-02-25 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-02-25 |
| Device Manufacturer Date | 2015-06-18 |
| Date Added to Maude | 2016-03-18 |
| 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 XPT CA 15-3 ASSAY |
| Generic Name | CA 15-3 IMMUNOASSAY |
| Product Code | MOI |
| Date Received | 2016-03-18 |
| Model Number | N/A |
| Catalog Number | 10327620 |
| Lot Number | 043159 |
| Device Expiration Date | 2016-06-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-03-18 |