MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-20 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[73344765]
The customer called to the technical support center (tsc) to report a bad chloride (cl) electrode, which caused patient results to be affected. The customer changed the cl electrode on (b)(6) 2017 due to recommended maintenance. The customer successfully ran calibration and qc was within range. Then the customer noticed that some of the results were high and reran qc, which was out. The customer changed the cl electrode on (b)(6) 2017 again, which resolved the issue. The tsc sent a replacement cl electrode. The cause of the discordant cl results was a failed electrode. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[73344766]
Discordant, falsely low chloride (cl) results were obtained on multiple samples on a advia 1800 instrument. Samples were repeated on same instrument, and recovered higher. The discordant results were reported to the physician(s). All samples were repeated on the same advia 1800 instrument. The repeat results were reported to the physician(s) for all samples. There are no reports of patient intervention or adverse health consequences due to the discordant cl results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00266 |
| MDR Report Key | 6508577 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-04-20 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | 3-1-2 MUSASHINO AKISHIMA REGISTRATION#: 3003637681 |
| 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | CGZ |
| Date Received | 2017-04-20 |
| Model Number | ADVIA 1800 |
| 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | JJE |
| Date Received | 2017-04-20 |
| Model Number | ADVIA 1800 |
| 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 | 2017-04-20 |