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 2017-03-16 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[70180990]
A siemens headquarters support center (hsc) reviewed the reported event. Hsc reviewed the data provided. The customer's quality control (qc) was in range at the time of the event. Hsc reviewed the process error log and found an aliquot probe bad sample detect (false transition) error ten (10) minutes before the sample was ran, but is not related to this issue. Hsc stated there was no evidence of a reagent well issue. Hsc did not find any foaming or reagent arm 2 delivery issues. The cause of the discordant, falsely depressed blood urea nitrogen result 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
[70180991]
A discordant, falsely depressed blood urea nitrogen result was obtained on a patient sample on a dimension vista 1500 instrument. The initial result was reported out to the physician(s). The customer tested a new sample on an alternate dimension vista instrument, resulting higher. The customer issued a corrected report to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed blood urea nitrogen result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00275 |
| MDR Report Key | 6411848 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-16 |
| Date of Event | 2017-02-17 |
| Date Mfgr Received | 2017-02-21 |
| Device Manufacturer Date | 2008-11-18 |
| Date Added to Maude | 2017-03-16 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION NUMBER: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-03-16 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-16 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-16 |