MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-09 for ADVIA 1800 073-A021 manufactured by Siemens Healthcare Diagnostics Inc..
[17893463]
Discordant advia 1800 phenytoin results were obtained on a patient sample. The result was reported and the physician questioned the result after treating the patient for an overdose in the emergency department. The sample was repeated and a corrected report was issued. There was no report of adverse health consequences or patient intervention due to the discordant phenytoin results.
Patient Sequence No: 1, Text Type: D, B5
[17986080]
The customer contacted the siemens technical service and complained that they had reported a discordant phenytoin result based on result flags from the advia 1800. A technical specialist (ts) worked with the customer via telephone to analyze the problem. Based on the information provided by the customer the ts was able to determine that the reason for the discordant result was due to incorrect customer definable low and high range flag settings for phenytoin, which led to an incorrect interpretation by the operator. The ts worked with the customer to input the correct flag settings. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2009-00225 |
| MDR Report Key | 1558257 |
| Report Source | 05,06 |
| Date Received | 2009-12-09 |
| Date of Report | 2009-11-22 |
| Date of Event | 2009-11-18 |
| Date Mfgr Received | 2009-11-22 |
| Date Added to Maude | 2010-06-08 |
| 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 G1 | JEOL LTD |
| Manufacturer Street | 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2009-12-09 |
| Model Number | NA |
| Catalog Number | 073-A021 |
| 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 | 2009-12-09 |