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 2017-05-11 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[75180288]
The customer contacted the siemens customer care center (ccc) to report the discordant direct bilirubin result. A siemens headquarters support center (hsc) specialist reviewed the information provided and did not find method or reagent lot issue, and quality controls (qc) was in range. The hsc specialist recommended that the customer ensure the instructions for use (ifu) guidelines should be followed and samples be checked prior to analysis for clots or bubbles and all reagents be checked for bubbles or foam prior to placement on the system. The cause of the discordant direct bilirubin result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[75180289]
A discordant, falsely low direct bilirubin result was obtained on a pediatric patient sample on an advia 1800 instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument, resulting higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant direct bilirubin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00311 |
| MDR Report Key | 6560599 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-14 |
| Date Added to Maude | 2017-05-11 |
| 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 | MQM |
| Date Received | 2017-05-11 |
| 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 | 2017-05-11 |
| 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 | 2017-05-11 |