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 2017-04-05 for ADVIA 1800 ANALYZER 10315183 manufactured by Siemens Healthcare Diagnostics Inc..
[71836538]
A siemens customer care center (ccc) specialist remotely confirmed that the calibration and quality control results were within range. No other discordant results were obtained by the customer. The cause of the discordant, falsely elevated lipase result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[71836539]
A discordant, falsely elevated lipase result was obtained on one patient sample on an advia chemistry 1800 instrument while using reagent lot 383921. The initial result was flagged by the instrument as a high result. The same sample was repeated on the same instrument and on another advia chemistry 1800 instrument, resulting lower. The initial discordant result was not reported to physician(s). One of the repeat results was reported to physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated lipase result. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the discordant, falsely elevated lipase result.
Patient Sequence No: 1, Text Type: D, B5
[75760630]
The initial mdr 2432235-2017-00250 was filed on april 5th 2017. Additional information (04/11/2017): a siemens technical applications specialist (tas) went to the customer site and checked the contamination avoidance settings on the instruments. The tas specialist found that the instrument that generated the discordant lipase result was not properly configured and was missing the avoidance settings for chol_c and trig, which could impact results and cause falsely elevated readings. The tas specialist configured this instrument with the correct settings and the customer has not encountered this issue since then. The avoidance settings on the other instrument were correct. The cause of the discordant, falsely elevated lipase result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00250 |
| MDR Report Key | 6461363 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-05 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-04-05 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | JEOL LTD. |
| Manufacturer Street | REGISTRATION # 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 96-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 96-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 ANALYZER |
| Generic Name | ADVIA 1800 ANALYZER |
| Product Code | CHI |
| Date Received | 2017-04-05 |
| Model Number | ADVIA 1800 ANALYZER |
| Catalog Number | 10315183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 1800 ANALYZER |
| Generic Name | ADVIA 1800 ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-05 |
| Model Number | ADVIA 1800 ANALYZER |
| Catalog Number | 10315183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 2017-04-05 |