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 2018-01-09 for ADVIA CENTAUR XP CA 125II ASSAY N/A 10310443 manufactured by Siemens Healthcare Diagnostics, Inc..
[96820458]
Siemens is investigating the lower advia centaur xp ca 125ii neat results. The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the instruction for use (ifu) under the limitation section states the following: "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. " mdr 1219913-2017-00260 was filed on 1/05/2018 for results from the same patient tested on a different day, and mdr 1219913-2017-00260 supplemental report 1 was filed on 01/09/2018 for additional information and correction.
Patient Sequence No: 1, Text Type: N, H10
[96820459]
Low advia centaur xp ca 125ii neat results were obtained on two samples from the same patient when run in duplicate the following day ((b)(6) 2017). The low neat results were considered discordant compared to higher ca 125ii dilution results. There are no reports that patient treatment was altered or prescribed or adverse health consequences due to the low advia centaur xp ca 125ii results..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2017-00262 |
| MDR Report Key | 7176602 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-09 |
| Date of Report | 2018-03-19 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2018-03-02 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2018-01-09 |
| 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 | STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | 1219913-02/18/2018-001-C |
| 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 | 2018-01-09 |
| Model Number | N/A |
| Catalog Number | 10310443 |
| Lot Number | 015173 |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-09 |