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 2017-01-23 for ADVIA CENTAUR XP BR (27.29 ) ASSAY N/A 10333349 manufactured by Siemens Healthcare Diagnostics, Inc..
[65631582]
A siemens customer service engineer (cse) was sent to the customer's site for system inspection. The cse performed a total service check and calibrated the ancillary probe at the cuvette, replaced the photo multiplier tube (pmt) due to cps signal errors, luminometer cover and worn o-ring, and checked dark counts. The dry, water, and wash 1 system checks were acceptable. The br (ca27. 29) assay was recalibrated, ten quality control (qc) replicates were run and the results were within qc range. Four patient samples previously observed for signal errors were repeated without errors. The cause for the discordant advai centaur xp br (ca 27. 29) is unknown. Siemens is investigating. The limitations section under the warning/note section of the instructions for use (ifu) states the following: "do not interpret levels of ca 27. 29 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 27. 29 within the range observed in healthy individuals. Additionally, elevated levels of ca 27. 29 can be observed in patients with nonmalignant diseases. Measurements of ca 27. 29 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. "
Patient Sequence No: 1, Text Type: N, H10
[65631583]
An elevated advia centaur xp br (assay for ca 27. 29) result was obtained by the customer on a patient sample (secondary tube). The result was questioned by the client due to a lower br test result from (b)(6). The same sample (secondary tube) was re-run neat, and the result was lower. The sample was run a third time, and the br results were elevated. The patient sample (same secondary tube), and another sample tube was pulled, re-run on an alternate advia centaur system (irl97140932), and the results were elevated. The original br result from (b)(6) was questioned by the physician. There are no known reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp br (assay for ca 27. 29) result.
Patient Sequence No: 1, Text Type: D, B5
[68126945]
Siemens filed the initial mdr 1219913-2016-00277 on (b)(6) 2017 for an elevated advia centaur xp br (assay for ca 27. 29) result on a patient sample. On 01/20/2017 - additional information: the patient result of 852 u/ml (auto-dilute 1:10) drawn on (b)(6) 2016, and the patient result of 1174 u/ml from (b)(6) 2016 were considered the correct results. On 02/01/2017 - additional information: based on the actions taken by the siemens customer service engineer (cse), and primarily the replacement of the pmt, there has been no further discordant patient results observed by the customer. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[71864988]
Siemens filed the initial mdr 1219913-2016-00277 on 01/23/2017 for an elevated advia centaur xp br (assay for ca 27. 29) result on a patient sample, and mdr 1219913-2016-00277 supplemental report 1 on 02/17/2017 for additional information. On 02/21/2017: correction - the repeat results ((b)(6) 2016) from another sample tube was for (b)(6) and not (b)(6) as originally reported. Please note that both sids are from the same patient. The instrument sn did not change, only the sid. Instrument sn: (b)(4), (b)(6). Repeat results from another sample tube: (b)(6) 2016 >450 (neat), 852 (auto-dilute 1:10). On 02/21/2017: additional information - the customer has provided the results of four other patients not originally provided. (b)(6). Based on the actions taken by the siemens customer service engineer (cse), and primarily the replacement of the pmt, there has been no further discordant patient results observed by the customer. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00277 |
| MDR Report Key | 6271665 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-23 |
| Date of Report | 2017-03-21 |
| Date of Event | 2016-12-26 |
| Date Mfgr Received | 2017-02-21 |
| Device Manufacturer Date | 2016-06-10 |
| Date Added to Maude | 2017-01-23 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. 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 | 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 BR (27.29 ) ASSAY |
| Generic Name | IMMUNOLOGICAL TEST FOR BR (27.29) ANTIGEN |
| Product Code | MOI |
| Date Received | 2017-01-23 |
| Model Number | N/A |
| Catalog Number | 10333349 |
| Lot Number | 53919219 |
| Device Expiration Date | 2017-02-10 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-23 |