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 2017-03-07 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[69328597]
The customer contacted a siemens customer care center and stated that they verified the probe alignment and sample quality. The cause of the discordant, falsely low wrcrp result on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[69328598]
A discordant, falsely low wide range c-reactive protein (wrcrp) result was obtained on one patient sample on an advia 1800 instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument, resulting higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low wrcrp result.
Patient Sequence No: 1, Text Type: D, B5
[73852481]
The initial mdr 2432235-2017-00167 was filed on march 7, 2017. Additional information (03/21/2017): a siemens headquarters support center (hsc) specialist reviewed the instrument data and did not find any device malfunction. The hsc specialist stated that the reaction curve was consistent with no sample for the reaction, which may be due to the sample handling issue like bubbles or foam. The hsc specialist stated that all samples should be checked for the presence of fibrin, or bubbles prior to analysis. Quality control was in range and no other patient samples were affected. The cause of the discordant, falsely low wide range c-reactive protein 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
| Report Number | 2432235-2017-00167 |
| MDR Report Key | 6384171 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-07 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-03-21 |
| Device Manufacturer Date | 2007-02-22 |
| Date Added to Maude | 2017-03-07 |
| 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 |
| 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 |
| Generic Name | ADVIA 1800 |
| Product Code | DCN |
| Date Received | 2017-03-07 |
| Model Number | ADVIA 1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | JJE |
| Date Received | 2017-03-07 |
| Model Number | ADVIA 1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-07 |