MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-20 for ADVIA 1800 073-A021 manufactured by Siemens Healthcare Diagnostics Inc..
[2162308]
A discordant high acetaminophen (acet) result was obtained with one (1) patient sample on an advia 1800. The result was reported to the physician, who questioned the result due to the patient's clinical history. The sample was re-tested in duplicate, and the corrected result was reported out. Patient treatment was not altered or prescribed. There were no reports of adverse health consequences due to the discordant acet result.
Patient Sequence No: 1, Text Type: D, B5
[9395100]
A siemens healthcare diagnostics inc. Fse (field service engineer) was dispatched to the customer site for instrument evaluation. The fse checked the hydraulics and operation, and proactively replaced a srwp (sample reagent wash pump). The fse also calibrated the system and ran qc. The qc results were within range. The actual cause could not be determined, and no conclusion can be drawn as to what caused the discordant result. The instrument is performing according to specifications. No further evaluation of the system is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00123 |
| MDR Report Key | 2255809 |
| Report Source | 05,06 |
| Date Received | 2011-09-20 |
| Date of Report | 2011-08-29 |
| Date of Event | 2011-08-29 |
| Date Mfgr Received | 2011-08-29 |
| Date Added to Maude | 2012-06-27 |
| 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 AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer City | NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | LDP |
| Date Received | 2011-09-20 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A021 |
| 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 | 2011-09-20 |