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 2017-02-14 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.
[67443015]
The customer contacted a siemens customer care center (ccc). The quality controls (qc) were within range on the day of the event. The siemens regional support center (rsc) investigated this issue and reviewed instrument data. The rsc found that the same reagent flex and reagent well set that the discrepant low result came from produced no other discrepant pbnp results. The rsc found that the pbnp qc data showed good precision and accuracy. The rsc discovered that the affected sample was the only one run in cups and the same sample was then transferred to small sample container (ssc) to perform repeat testing on the alternate dimension vista instrument. The rsc concluded that the event was a sample specific issue. A siemens headquarters support center specialist reviewed the instrument data and discovered that the pressure profile during aliquotting showed an atypical profile, which is consistent with a sample integrity issue. The cause of discordant, falsely depressed pbnp 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
[67443016]
A discordant, falsely depressed n-terminal pro-brain natriuretic peptide (pbnp) result was obtained on a patient sample on a dimension vista 1500 instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate dimension vista instrument, resulting higher. It is unknown if the corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed pbnp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00165 |
| MDR Report Key | 6330356 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-14 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-01-25 |
| Device Manufacturer Date | 2016-02-11 |
| Date Added to Maude | 2017-02-14 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 | NBC |
| Date Received | 2017-02-14 |
| 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 19702 US 19702 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-14 |
| 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 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-14 |