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 2017-04-26 for ADVIA 1800 ANALYZER manufactured by Siemens Healthcare Diagnostics Inc..
[74069266]
The falsely elevated lipase result was obtained from an advia 1800 instrument which also runs the triglyceride assay. The triglyceride assay is not run on the advia 1800 instrument from which the lower lipase result was obtained. A siemens customer care center (ccc) specialist stated that the avoidance settings to prevent interference between the triglyceride assay and the lipase assay had been implemented on the advia 1800 instruments. The customer is continuing to measure lipase on the advia 1800 instrument that does not run the triglyceride assay. The cause of the discordant, falsely elevated lipase result is unknown. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[74069267]
A patient sample was evaluated for lipase on two advia 1800 instruments. The lipase result from one instrument was falsely elevated compared to the result from the other instrument. The discordant, falsely elevated lipase result as well as the lower lipase result were not reported to physician(s). The lower lipase result was in alignment with the clinical picture and medical history of the patient. There are no known reports of patient intervention due to the falsely elevated lipase result. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the falsely elevated lipase result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00293 |
| MDR Report Key | 6522555 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-26 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-04-26 |
| 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 | 2017-04-26 |
| Model Number | ADVIA 1800 |
| 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 | 2017-04-26 |
| Model Number | ADVIA 1800 |
| 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 | 2017-04-26 |