MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-10 for ADVIA CENTAUR CP 086-A001-01 manufactured by Siemens Healthcare Diagnostics Inc..
[18495306]
Discordant advia centaur cp myoglobin results were obtained on patient samples. The results were reported to the physician. Upon retest, the corrected results were reported to the physician. There was no report of patient intervention or adverse health consequences due to the discordant myoglobin results.
Patient Sequence No: 1, Text Type: D, B5
[18688050]
A siemens healthcare field service engineer (fse) was sent to the customer site. Analysis of the instrument and instrument data indicate that the cause for the discordant myoglobin results was due to the malfunction of the sample diluter and the sample syringe. The instrument was repaired. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2009-00139 |
| MDR Report Key | 1473312 |
| Report Source | 05,06 |
| Date Received | 2009-07-10 |
| Date of Report | 2009-06-29 |
| Date of Event | 2009-06-29 |
| Date Mfgr Received | 2009-06-29 |
| Date Added to Maude | 2010-07-16 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | ROBION 8212 NEUHAUSEN A. RHK & STRATEC |
| Manufacturer Street | GEWERBESTRASSE 6 GEWERBESTRAFE 37 |
| Manufacturer City | D75217 |
| Manufacturer Postal Code | D75217 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNO-ASSAY ANALYZER |
| Product Code | MVE |
| Date Received | 2009-07-10 |
| Model Number | ADVIA CENTAUR CP |
| Catalog Number | 086-A001-01 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| 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 | 2009-07-10 |