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 2013-08-30 for ADVIA 2400 073-A011-02 manufactured by Siemens Healthcare Diagnostics Inc..
[3840515]
Discordant, falsely elevated digoxin results were obtained on three patient samples on an advia 2400 instrument. Two samples were from patient 1 and one sample from patient 2. The initial result for patient 2 was released to the physician(s) and both results for patient 1 were held for validation and not reported. The patient samples were repeated on the same instrument, and the expected results were obtained. The rerun results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated digoxin results.
Patient Sequence No: 1, Text Type: D, B5
[11130001]
The customer contacted the siemens technical solutions center (tsc). After evaluation of the instrument data, the tsc advised the customer to replace the lamp. A siemens field service engineer (fse) was also dispatched to the customer site. The customer had replaced the lamp prior to the fse visit, and the fse verified the instrument is within specification. The samples were repeated on the same instrument with new digoxin quality control material after replacing the lamp and results were as expected. The cause of the discordant, falsely elevated digoxin result is a malfunction of the lamp. 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 | 2432235-2013-00424 |
| MDR Report Key | 3319217 |
| Report Source | 01,05,06 |
| Date Received | 2013-08-30 |
| Date of Report | 2013-08-05 |
| Date of Event | 2013-07-17 |
| Date Mfgr Received | 2013-08-05 |
| Date Added to Maude | 2013-12-02 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KXT |
| Date Received | 2013-08-30 |
| Model Number | ADVIA 2400 |
| Catalog Number | 073-A011-02 |
| 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 | 2013-08-30 |