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 2017-10-16 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[90434468]
The customer contacted the siemens customer care center (ccc) to report discordant microalbumin results when testing from the automation system. A siemens customer service engineer (cse) was dispatched to the customer site. The cse checked and adjusted probe alignments. The cse checked the system for bacterial contamination. The cse found that the system was contaminated. The cse installed a micro-filter and decontaminated the system and lab automation. The cse performed a bacterial contamination test and was found positive. A siemens headquarter support center (hsc) reviewed the information provided and concluded there was not a method or reagent issue. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[90434469]
Discordant, microalbumin repeat results were obtained on one patient sample on an advia 1800 instrument. The discordant results were not reported to the physician(s). The sample was repeated on the same instrument. The initial result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, microalbumin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00556 |
| MDR Report Key | 6952485 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-16 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-09-22 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-10-16 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| 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 | CJW |
| Date Received | 2017-10-16 |
| Model Number | ADVIA 1800 |
| 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | JJE |
| Date Received | 2017-10-16 |
| Model Number | ADVIA 1800 |
| 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 | 2017-10-16 |