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 2017-08-21 for DIMENSION VISTA 500 DIMENSION VISTA? 500 manufactured by Siemens Healthcare Diagnostics Inc..
[83134669]
The customer contacted the siemens customer care center (ccc) to report the discordant total bilirubin result. Quality control (qc) was within range on the date of the event. The customer declined troubleshooting. The customer found that the repeat had insufficient sample which caused the repeat result to be discrepantly low. This instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[83134670]
A discordant, falsely low total bilirubin result was obtained on one patient sample upon repeat testing on a dimension vista 500 instrument. The initial result had been higher and was reported to the physician(s). The discordant, falsely low result was also reported to the physician(s), who questioned it. The operator issued a corrected report with the initial result, which matched the clinical picture of the patient. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low total bilirubin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00662 |
| MDR Report Key | 6807218 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-21 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-08-29 |
| Device Manufacturer Date | 2013-03-28 |
| Date Added to Maude | 2017-08-21 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD REGISTRATION # : 1226181 |
| 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 | DIMENSION VISTA 500 |
| Product Code | MQM |
| Date Received | 2017-08-21 |
| Model Number | DIMENSION VISTA? 500 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 500 |
| Generic Name | DIMENSION VISTA 500 |
| Product Code | JJE |
| Date Received | 2017-08-21 |
| Model Number | DIMENSION VISTA? 500 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-21 |