MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-20 for ADVIA CHEMISTRY 1800 073-A021 manufactured by Siemens Healthcare Diagnostics, Inc..
[2730532]
Discordant advia chemistry 1800 creatinine kinase (cknac) results were obtained on two patient samples. The results were questioned by the nurse, so the laboratory repeated the samples on the same system with higher results. There are no known reports of adverse health consequences due to the discordant cknac results.
Patient Sequence No: 1, Text Type: D, B5
[9925579]
A siemens fse (field service engineer) was dispatched to the customer site to evaluate the advia chemistry 1800 instrument. After analysis of the instrument, the fse replaced the reagent pipettor probe 1 (rpp1) transfer mechanism and checked alignments. The instrument is performing within specifications. No further evaluation of the device is needed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00197 |
| MDR Report Key | 2622955 |
| Report Source | 05,06 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-05-27 |
| Date of Event | 2012-05-27 |
| Date Mfgr Received | 2012-05-27 |
| Date Added to Maude | 2012-10-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY 1800 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2012-06-20 |
| Model Number | ADVIA CHEMISTRY 1800 |
| Catalog Number | 073-A021 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH 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 | 2012-06-20 |