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 2017-02-10 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[67234821]
The customer contacted the siemens customer care center (ccc) and stated that the quality controls(qc) were within range on the day of the event. A siemens technical application specialist (tas) was dispatched to the customer site. Tas noticed that the reaction tray wash unit (wud) was overflowing. Tas checked the water pressure, which was higher than expected. Tas lowered the water pressure to normal. Tas checked oil bath, which was contaminated due to overflowing wud. Tas removed water with a syringe and ran calibration and qc, which passed. Tas ran precision testing, which passed. The cause of the discordant, falsely elevated bun result on a patient sample 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
[67234822]
A discordant, falsely elevated blood urea nitrogen (bun) result was obtained on a patient sample on an advia 1800 instrument. The discordant result was reported to the physician(s). The sample was repeated on the same instrument, resulting lower. A new sample was collected from the patient and tested on the same instrument, resulting lower and matching with the repeat result. The corrected result obtained on the new sample was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated bun result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00116 |
| MDR Report Key | 6322157 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-15 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-02-10 |
| 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. (REGISTRATION # 3003637681) |
| Manufacturer Street | 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 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-02-10 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-10 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-10 |