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 2017-04-14 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[72853446]
A siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and determined that there was no device malfunction. The hsc specialist stated the customer receives the samples in frozen state therefore the samples must be thawed and mixed prior to analysis. Additionally, the samples should be mixed and checked for fibrin particles and bubbles prior to analysis. The hsc specialist stated that the issue may have occurred due to an improper sample handling, poor mixing or bubbles in the tubes at the time of analysis, which can cause a poor aspiration and impact result. The cause of the discordant, falsely low ammonia result on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[72853447]
A discordant, falsely low ammonia result was obtained on one patient sample on an advia 1800 instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument, resulting higher. The repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low ammonia result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00261 |
| MDR Report Key | 6493536 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2015-12-17 |
| Date Added to Maude | 2017-04-14 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | JEOL LTD. (REGISTRATION # 3003637681) |
| Manufacturer Street | 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 | JIF |
| Date Received | 2017-04-14 |
| 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 | 2017-04-14 |
| 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 | 2017-04-14 |