MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-02-03 for ADVIA CENTAUR XP GENTAMICIN (GENT) ASSAY N/A 05223979 manufactured by Siemens Healthcare Diagnostics, Inc..
[37430318]
The cause for the discordant advia centaur xp gentamicin (gent) results is unknown. Siemens healthcare diagnostics is investigating. The instrument is performing within specifications. The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the ifu state in the preparing the samples sections: "before placing samples on the system, ensure that samples have the following characteristics:? Samples are free of fibrin or other particulate matter. ? Samples are free of bubbles. "
Patient Sequence No: 1, Text Type: N, H10
[37430319]
An elevated advia centaur xp gentamicin (gent) result was obtained on a patient sample. The patient sample was grossly haemolysed. A second sample was obtained and tested. The result was low. The patient samples were repeated. The results were similar to the initial results. The initial result was reported to the physician and was questioned. The result from the second sample was considered correct as it matched the patient's clinical condition. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant gentamicin result.
Patient Sequence No: 1, Text Type: D, B5
[39575060]
Siemens filed the initial mdr 1219913-2016-00018 on february 03, 2016. 02/17/2016 additional information: the initial elevated results could be attributed to a sampling issue. An interferent would not be expected to be released with a hemolytic sample that would cause the elevated result. The patient sample is not available for interference testing (heterophillic blocking tube and dilution). Therefore, a cause could not be identified. The customer requested information that is related to possible causes for elevated results with the advia centaur xp gentamicin assay. The only information related to the effects of compounds with the performance of the advia centaur xp gentamicin assay are listed in the performance characteristics section of the ifu (instructions for use, 10629848_en rev. F, 2014-08). The cause for the discordant gentamicin results is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2016-00018 |
| MDR Report Key | 5406570 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-15 |
| Date of Event | 2015-12-23 |
| Date Mfgr Received | 2016-02-17 |
| Device Manufacturer Date | 2015-06-09 |
| Date Added to Maude | 2016-02-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| 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 GENTAMICIN (GENT) ASSAY |
| Generic Name | GENTAMICIN IMMUNOASSAY |
| Product Code | LCD |
| Date Received | 2016-02-03 |
| Model Number | N/A |
| Catalog Number | 05223979 |
| Lot Number | 210 |
| Device Expiration Date | 2016-08-09 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |