MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-24 for ADVIA CENTAUR XP 078-A010-XX manufactured by Siemens Healthcare Diagnostics, Inc..
[3371370]
Two (2) discordant high creatinine-kinase mb (ck-mb) results were generated by the advia centaur xp system following a monthly cleaning procedure. Quality controls were out of specification at the time the samples were processed. The initial results were reported out of the laboratory. The samples were retested and a corrected ck-mb result was obtained and reported to the physician. The customer provided results for a single patient event. There were no reports of adverse health consequences or known patient intervention due to the discordant ck-mb result.
Patient Sequence No: 1, Text Type: D, B5
[10404470]
The customer contacted siemens healthcare diagnostics technical solutions center (tsc). After reviewing the information, the tsc determined that the cause of the event is unknown. The tsc instructed the customer to repeat the monthly cleaning procedure using only water. Quality controls were within specification following these steps. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00034 |
| MDR Report Key | 2928981 |
| Report Source | 05,06 |
| Date Received | 2013-01-24 |
| Date of Report | 2012-12-30 |
| Date of Event | 2012-12-30 |
| Date Mfgr Received | 2012-12-30 |
| Device Manufacturer Date | 2011-06-13 |
| Date Added to Maude | 2013-04-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMIT |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, CO., DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-01-24 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-XX |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER HEALTH CARE 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 | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-24 |