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 2017-04-07 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[72413901]
A siemens customer service engineer (cse) was dispatched to the customer's site. The cse found gel on aliquot and sample probe 2. Reagent probe 4 failed system check precision. The cse found excessive serum buildup on the aptio vista buffer static discharge plate. The cse ran server 2 service methods and system check. The cse cleaned the static discharge place and all aliquot probe touch points. The cse replaced the aliquot, sample probe 2 and reagent probe 4 probes. The cse ran auto-alignment and quickcheck, resulting within specifications and range. The cse reran reagent probe 4 system check, resulting within specification and range. The customer performed a 5 test correlation study, resulting within range. The cause of the discordant, falsely elevated total bilirubin 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
[72413902]
A discordant, falsely elevated total bilirubin result was obtained on a patient sample on a dimension vista 1500 instrument. The initial result was not reported out to the physician(s). The customer repeated the same sample on an alternate dimension vista instrument, resulting lower. The customer repeated the same sample on the original instrument, resulting lower. After service was provided, the repeat result was reported out to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00363 |
| MDR Report Key | 6474323 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-03-13 |
| Date Mfgr Received | 2017-03-13 |
| Device Manufacturer Date | 2015-10-20 |
| Date Added to Maude | 2017-04-07 |
| 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 | MQM |
| Date Received | 2017-04-07 |
| 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 | 2017-04-07 |
| 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 | 2017-04-07 |