MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-03-04 for ADVIA CENTAUR MYOGLOBIN (MYO) 09011232 manufactured by Siemens Healthcare Diagnostics Inc..
[15700603]
Two falsely suppressed advia centaur myoglobin results were obtained on pt samples. Repeat testing was performed on the pt samples and the test results were higher. The second pt sample was tested on the advia centaur cp and the result was much higher than the repeat on the advia centaur. Pt treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant myoglobin results.
Patient Sequence No: 1, Text Type: D, B5
[15985907]
A siemens field service engineer (fse) was sent to the customer site. Analysis of the instrument and instrument data indicated that the sample probe vertical pulley needed adjustment. The fse readjusted and tightened the vertical pulley and recalibrated the sample probe. The instrument is performing within specifications. No further eval of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[15840511]
Two falsely suppressed advia centaur myoglobin results were obtained on pt samples. Repeat testing was performed on the pt samples and the test results were higher. The second pt sample was tested on the advia centaur cp and the result was much higher than the repeat on the advia centaur. Pt treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant myoglobin results.
Patient Sequence No: 2, Text Type: D, B5
[16139355]
A siemens field service engineer (fse) was sent to the customer site. Analysis of the instrument and vertical pulley needed adjustment. The fse readjusted and tightened the vertical pulley and recalibrated the sample probe. The instrument is performing within specifications. No further eval of the device is required.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 1219913-2009-00022 |
| MDR Report Key | 1334966 |
| Report Source | 05,06 |
| Date Received | 2009-03-04 |
| Date of Report | 2009-02-17 |
| Date of Event | 2009-02-17 |
| Date Mfgr Received | 2009-02-17 |
| Date Added to Maude | 2010-08-21 |
| 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 | EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY ST. |
| 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 ST. |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR MYOGLOBIN (MYO) |
| Generic Name | MYOGLOBIN IMMUNOASSAY |
| Product Code | DDR |
| Date Received | 2009-03-04 |
| Model Number | NA |
| Catalog Number | 09011232 |
| Lot Number | 055160 |
| ID Number | NA |
| Device Expiration Date | 2009-11-24 |
| 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 | 2009-03-04 | |
| 2 | 0 | 2009-03-04 |