MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-29 for ADVIA CENTAUR XP MYOGLOBIN (MYO) ASSAY N/A 09011232 manufactured by Siemens Healthcare Diagnostics, Inc..
[3256869]
A false low advia centaur xp myoglobin result was obtained on a patient sample and the result was considered discordant when compared with the previous result. Repeat testing was performed on the second instrument in the laboratory and the result was higher. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant myoglobin result.
Patient Sequence No: 1, Text Type: D, B5
[10589408]
The cause for the discordant advia centaur xp myoglobin result is unknown. The quality control and calibrations were acceptable. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the summary and explanation of the test: "myoglobin has a negative predictive value of 99%, which improves the rule out capabilities of the emergency department and helps reduce the number of patients inappropriately admitted to the coronary care units with symptoms atypical of acute myocardial infarction. When used in combination with other cardiac markers such as ck-mb or troponin i, myoglobin is a valuable diagnostic tool to be used in the early evaluation of the potential acute myocardial infarction patient. "
Patient Sequence No: 1, Text Type: N, H10
[10672363]
(b)(4). On (b)(4) 2013: a siemens field service engineer (fse) was sent to the customer site. The fse performed a total service call. The fse adjusted the sample and reagent probes to cuvette bottom down two steps. A precision run was performed and the results were good. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2013-00067 |
| MDR Report Key | 3026956 |
| Report Source | 05,06 |
| Date Received | 2013-03-29 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-03-01 |
| Date Mfgr Received | 2013-04-06 |
| Date Added to Maude | 2013-05-29 |
| 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 | 0 |
| Event Location | 0 |
| 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 MYOGLOBIN (MYO) ASSAY |
| Generic Name | MYOGLOBIN IMMUNOLOGICAL TEST SYTEM |
| Product Code | DDR |
| Date Received | 2013-03-29 |
| Model Number | N/A |
| Catalog Number | 09011232 |
| Lot Number | 055175 |
| ID Number | N/A |
| Device Expiration Date | 2013-12-09 |
| 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 | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-29 |