MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-03-31 for ADVIA CHEMISTRY 2400 ANALYZER ADVIA 2400 073-A011-02 manufactured by Siemens Healthcare Diagnostics Inc..
[5681146]
The customer has obtained discordant results on four patient samples for the hemoglobin a1c_3 assay on an advia chemistry 2400 instrument. The results were either compared to previous results obtained on the patient or an alternate platform. Patient results were not reported to the physician(s). Additional details regarding the patient samples is provided. There were no reports of adverse health consequences due to the discordant hemoglobin a1c_3 results.
Patient Sequence No: 1, Text Type: D, B5
[13043443]
A siemens field service engineer (fse) and a technical assay specialist (tas) were dispatched to the customer site. The fse and the tas analyzed the instrument, instrument data, and patient results and did not find any instrument or maintenance related issues that could have caused the discordant results on the patient samples. The cause of the discordant hemoglobin a1c_3 results 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 | 2432235-2015-00148 |
| MDR Report Key | 4645854 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-06 |
| Date of Event | 2015-01-20 |
| Date Mfgr Received | 2015-03-06 |
| Date Added to Maude | 2015-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | JEOL LTD (REG# 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 CHEMISTRY 2400 ANALYZER |
| Generic Name | ADVIA CHEMISTRY 2400 ANALYZER |
| Product Code | PDJ |
| Date Received | 2015-03-31 |
| Model Number | ADVIA 2400 |
| Catalog Number | 073-A011-02 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-31 |