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 2017-06-23 for DIMENSION VISTA1500 manufactured by Siemens Healthcare Diagnostics Inc..
[78274508]
The customer contacted the siemens technical support center (tsc) to report the discordant total bilirubin result. The tsc suggested to the customer to run quality control (qc) 3 times on each level, and it was all good. The customer ran patient correlation, and results matched. A siemens customer service engineer (cse) was dispatched to the customer site. The cse ran qc 10 times for all levels, resulting within range. The cse ran align mix and overmix for server 2, aligned reagent arm 3 (r3) and reagent arm 4 (r4), and ran quick check, which passed. The cse ran total bilirubin samples, and all results were in range. The cse reran service methods, and all passed. The cause of the discordant total 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
[78274509]
A discordant, total bilirubin result was obtained on one patient sample on a dimension vista 1500 instrument. The initial result was reported to the physician(s). The sample was repeated on the same instrument and on an alternate dimension vista instrument (dv311190), resulting lower. The repeat result was not reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant total bilirubin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00533 |
| MDR Report Key | 6663301 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-05-29 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2013-08-22 |
| Date Added to Maude | 2017-06-23 |
| 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 AVENUE |
| 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 NUMBER: 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 VISTA1500 |
| Generic Name | DIMENSION VISTA1500 |
| Product Code | MQM |
| Date Received | 2017-06-23 |
| Model Number | DIMENSION VISTA1500 |
| 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 VISTA1500 |
| Generic Name | DIMENSION VISTA1500 |
| Product Code | JJE |
| Date Received | 2017-06-23 |
| Model Number | DIMENSION VISTA1500 |
| 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 | 2017-06-23 |