MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-18 for ADVIA CHEMISTRY 1800 SYSTEM manufactured by Siemens Healthcare Diagnostics Inc..
[83135521]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site. The cse inspected the instrument and checked the probe alignments, checked the functionality of the mixer, checked the reaction tray wash unit and dilution tray wash unit. Precision tests were performed and no issues were observed. The cause of the falsely low discordant urine total protein result is unknown. The analyzer is performing according to specifications. No further action required. Mdr 2432235-2017-00487 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[83135522]
A falsely low discordant urine total protein test result was obtained on an advia 1800 system for one patient. The initial result was not reported to the physician(s). The same sample from the same patient was repeated on the same system five times. One of the repeat results was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low discordant urine total protein result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00488 |
| MDR Report Key | 6805427 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-18 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2017-08-18 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE PO BOX 6101 |
| Manufacturer City | TARRYTOWN NY 105916101 |
| Manufacturer Country | US |
| Manufacturer Postal | 105916101 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 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 CHEMISTRY 1800 SYSTEM |
| Generic Name | ADVIA CHEMISTRY 1800 SYSTEM |
| Product Code | JGQ |
| Date Received | 2017-08-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 CHEMISTRY 1800 SYSTEM |
| Generic Name | ADVIA CHEMISTRY 1800 SYSTEM |
| Product Code | JJE |
| Date Received | 2017-08-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-08-18 |