MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-23 for ADVIA CENTAUR CP 086-A002-01 manufactured by Siemens Healthcare Diagnostics, Inc..
[4652480]
A (b)(6) result was obtained on a patient sample when repeat testing was performed by the customer. The patient's initial (b)(6) test result was positive and it is the laboratory's protocol to repeat initially (b)(6) test results with an index result between one and eleven. The patient sample was repeated a second time two days later and the hcv results were (b)(6). A result was reported. There was no report of patient intervention or adverse health consequences due to the (b)64) assay repeat result.
Patient Sequence No: 1, Text Type: D, B5
[12000683]
A siemens customer service engineer (cse) was sent to the customer site for instrument inspection. After evaluation of the instrument and instrument data, the cse decontaminated the system including the acid and base lines, replaced the waste, water and wash 1 tubing from the system to the bulk bottles, lubricated the sample syringe, checked the probe calibrations, and cleaned the databases and defragmented the hard drives. The cause for the discordant hcv result is unknown. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00388 |
| MDR Report Key | 3889276 |
| Report Source | 05,06 |
| Date Received | 2014-06-23 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-14 |
| Date Mfgr Received | 2014-05-30 |
| Date Added to Maude | 2014-07-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | STRATEC BIOMEDICAL SWITZERLAND AG |
| Manufacturer Street | NEUWIESENSTRASSE 4 REGISTRATION NUMBER 3008494306 |
| Manufacturer City | BERINGEN, 8222 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8222 |
| 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 | OBF |
| Date Received | 2014-06-23 |
| Model Number | ADVIA CENTAUR CP |
| Catalog Number | 086-A002-01 |
| ID Number | N/A |
| Operator | MEDICAL TECHNOLOGIST |
| 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 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-23 |