MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-05-25 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[76033378]
A siemens headquarters support center (hsc) reviewed the event. Hsc stated siemens does not have validated instrument parameters and does not support the use of the immunalysis eddp method on the advia 1800. This reagent is distributed by siemens for use with the viva instrument product line only. The use of this reagent on the advia instrumentation has not been studied and siemens has no claims of performance of this reagent with this analyzer model. Using this reagent on the advia instrument is non-standard use and not supported by siemens. The cause of the discordant, falsely elevated eddp result is due to user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[76033379]
A discordant, falsely elevated eddp (metabolite of methadone) result was obtained on a patient sample on an advia 1800 instrument. The initial result was released to the physician(s), which was questioned. The customer repeated the same sample on the same advia 1800 instrument, resulting lower. The customer repeated the same sample four additional times, confirming the first repeat result. The customer issued a corrected report with the first repeat result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated eddp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00241 |
| MDR Report Key | 6592928 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-05-01 |
| Date Added to Maude | 2017-05-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DJR |
| Date Received | 2017-05-25 |
| Model Number | ADVIA 1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-25 |
| Model Number | ADVIA 1800 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |