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 2017-03-21 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[70456305]
The customer contacted the siemens customer care center (ccc) and allowed siemens remote service (srs) access. The customer stated that the instrument was the only dimension vista that the samples were run on. The customer performed patients' sample comparison between that dimension vista instrument and an alternate dimension vista instrument and the results were comparable. The customer ran quality controls (qc) for levels 1 and 3, resulting within range. The customer ran calibration, resulting acceptable. The customer stated that they believe that the original sample was mixed up with another sample. The cause of the discordant, falsely elevated tbil results 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
[70456306]
Discordant, falsely elevated total bilirubin (tbil) results were obtained on a neonatal patient sample on a dimension vista 500 instrument. The initial discordant result was reported to the maternity ward and the physician(s) questioned the result. A new sample from the infant drawn two hours later resulted lower. The result from the new sample was reported to the physician(s). The original sample was then repeated on the same dimension vista instrument, matching the initial discordant result. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tbil results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00280 |
| MDR Report Key | 6420972 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2017-02-23 |
| Device Manufacturer Date | 2013-05-16 |
| Date Added to Maude | 2017-03-21 |
| 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 | MS. 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 #: 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | MQM |
| Date Received | 2017-03-21 |
| Model Number | DIMENSION VISTA 500 |
| 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | JJE |
| Date Received | 2017-03-21 |
| Model Number | DIMENSION VISTA 500 |
| 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 | 2017-03-21 |