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 2016-07-19 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[49914896]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse took out the luminometer and cleaned it. The cse ran dark counts several times and obtained interference. The cse cleaned the ionizer fan and cuvette bin and reran dark counts, which were acceptable. During the follow-up visits, the cse replaced the luminometer and ionizer and then performed the assay calibration, which failed. The cse replaced the wash block assembly, verified that there were no leaks and the acid and base dispenses were functioning properly. The cse performed daily cleaning and ran calibrations and quality controls, which were acceptable. The cause of the discordant ca 27. 29 results on two patient samples is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[49914897]
A discordant, falsely low cancer antigen 27. 29 (ca 27. 29) result was obtained on one patient sample on (b)(6) 2016 on an advia centaur cp instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument and resulted higher and as expected based on the patient's history. The corrected result was reported to the physician(s). The operator then performed a look-back on other patient samples and discovered one additional discordant ca 27. 29 result from (b)(6) 2016. The discordant result was falsely high and had been reported to the physician(s). The sample was repeated on the same instrument and resulted lower and aligned with the patient's history. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant ca 27. 29 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00384 |
| MDR Report Key | 5806019 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-19 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-06-28 |
| Date Mfgr Received | 2016-07-01 |
| Date Added to Maude | 2016-07-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | STRATEC BIOMEDICAL SWITZERLAND AG |
| Manufacturer Street | REGISTRATION #: 3008494306 GEWERBESTRASSE 6 |
| Manufacturer City | NEUHAUSEN AM RHEINFALL, 8212 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2016-07-19 |
| Model Number | ADVIA CENTAUR CP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-07-19 |
| Model Number | ADVIA CENTAUR CP |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-19 |