MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-02-06 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[66603277]
The distributor contacted a siemens customer care center specialist and stated that the operators had obtained abnormal reaction curves while running the patient samples. Reaction curves suggested that the reagent was not added. Some abnormal reaction curves also had variance flags, which mean that photometric tests assay data was imprecise. A siemens headquarters support center (hsc) specialist reviewed the reaction curve data and determined that there was no systemic instrument or reagent issue. The information provided was consistent with a sample or reagent delivery issue. The hsc specialist recommended that prior to placement of the reagent or samples on the system, the materials should be checked for foam or bubbles, which can cause poor aspiration and impact results. Poor mixing could also impact results and may produce similar flags. The cause of the discordant wrcrp results on multiple patient samples 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
[66603278]
The customer of an advia 2400 instrument obtained discordant wide range c-reactive protein (wrcrp) results on multiple patient samples. The initial results had abnormal reaction curves. The initial results were not reported to the physician(s). The samples were repeated on the same instrument and correct reaction curves were obtained for the repeat runs. It is unknown if the repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant wrcrp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00100 |
| MDR Report Key | 6304062 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-02-06 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-01-12 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2017-02-06 |
| 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 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | DCN |
| Date Received | 2017-02-06 |
| Model Number | ADVIA 2400 |
| 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 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | JJE |
| Date Received | 2017-02-06 |
| Model Number | ADVIA 2400 |
| 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 | 2017-02-06 |