MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-16 for ADVIA CENTAUR XP TOBRAMYCIN N/A 03329534 manufactured by Siemens Healthcare Diagnostics, Inc..
[4548873]
Customer reported a low advia centaur xp tobramycin peak sample result that was questioned by the physician. Upon repeat testing of the same sample, the result was higher and in agreement with the patient's clinical picture. A trough sample drawn from the same patient result was as expected. The patient was not treated based on the initial result. There are no reports of adverse health consequences based on the initial low advia centaur xp tobramycin result.
Patient Sequence No: 1, Text Type: D, B5
[11855177]
The peak sample was a green top, no gel microtainer tube. The sample was spun in a microtainer centrifuge at a lipoclear setting (less than 60 seconds. ) no red cells were observed in the sample. The sample was transferred to a siemens sample tube for testing. The repeat testing used the same sample transferred to a siemens sample cup. The trough sample was also drawn into a green top-no gel microtainer tube and transferred to a siemens sample tube for testing. No conclusions can be drawn regarding sample handling. The cause of the non-reproducible advia centaur xp tobramycin result is unknown. Siemens field service engineer went on site and performed a precision study. All %cvs were low and all controls on all assays were in range. The system is performing within specification. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2014-00092 |
| MDR Report Key | 3753860 |
| Report Source | 05,06 |
| Date Received | 2014-04-16 |
| Date of Report | 2014-03-24 |
| Date of Event | 2014-03-24 |
| Date Mfgr Received | 2014-03-24 |
| Date Added to Maude | 2014-06-09 |
| 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 | 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 | 2014-04-16 |
| Model Number | N/A |
| Catalog Number | 03329534 |
| Lot Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-04-16 |