MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-14 for ADVIA CENTAUR XP TOBRAMYCIN N/A 03329524 manufactured by Siemens Healthcare Diagnostics, Inc..
[4239821]
Customer observed that repeated advia centaur xp tobramycin (tobr) results from the same patient did not reproduce. There are no reports that treatment was altered or prescribed based on the results. There are no reports of adverse health consequences based on the non-reproducible advia centaur xp torbramycin results.
Patient Sequence No: 1, Text Type: D, B5
[11549222]
The cause of the non-reproducible advia centaur xp tobramycin results is unknown. A siemens field service engineer (fse) was sent to the customer site for system inspection. The fse performed a total service call and found the aspirate probe 2 pinch valve not functioning and not closing and replaced the pin. The check valves 1 and 2 were tested. The fse ran quality control material and found the system to be operating properly. The system was fully functional upon departure. No conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00062 |
| MDR Report Key | 3679392 |
| Report Source | 05,06 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-02-17 |
| Date of Event | 2014-01-30 |
| Date Mfgr Received | 2014-02-17 |
| Date Added to Maude | 2014-05-19 |
| 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 | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP TOBRAMYCIN |
| Generic Name | FLUORESCENT IMMUNOASSAY, TOBRAMYCIN |
| Product Code | LCR |
| Date Received | 2014-03-14 |
| Model Number | N/A |
| Catalog Number | 03329524 |
| Lot Number | NOT AVAILABLE |
| ID Number | N/A |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-14 |