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 2014-06-26 for ADVIA 2400 073-A011-02 manufactured by Siemens Healthcare Diagnostics Inc..
[21489939]
A discordant, falsely elevated chloride (cl) result was obtained on one patient sample on an advia 2400 instrument. The discordant result was released to the pathologist(s), who questioned it. The sample was repeated on an alternate instrument, resulting lower. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated cl result.
Patient Sequence No: 1, Text Type: D, B5
[21577977]
The customer contacted the siemens technical solutions center (tsc). The customer stated that after replacing the ion selective electrode (ise) buffer, they did not perform ise calibrations prior to running patient samples. The customer re-calibrated the ise and ran quality controls, resulting within range. The cause of the discordant, falsely elevated cl result is a user error. 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 | 2432235-2014-00382 |
| MDR Report Key | 3898622 |
| Report Source | 01,05,06 |
| Date Received | 2014-06-26 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-06-03 |
| Date Mfgr Received | 2014-06-04 |
| Date Added to Maude | 2014-07-17 |
| 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 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION NUMBER:3003637681 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 2400 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CGZ |
| Date Received | 2014-06-26 |
| 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 | 2014-06-26 |