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 2017-03-28 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[71097817]
The customer contacted a siemens customer care center (ccc) specialist. The ccc was granted permission to remotely connect. The ccc reviewed the instrument data. The ccc found the customer's quality control (qc) was out at the time of the event. The ccc reviewed a precision study that was performed and found that it was within range. The ccc found reagent probe 3 out of alignment and a system test was out of range. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse performed bottom of cuvette corrections. The cse performed quickcheck, resulting within range. The cse ran qc and patient samples, 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
[71097818]
Discordant, falsely elevated total bilirubin results were obtained on nine patient samples on a dimension vista 1500 instrument. The initial results were reported out to the physician(s), which were questioned. The customer repeated the same samples on an alternate dimension vista instrument, resulting lower. The customer repeated the same samples on another alternate instrument, resulting lower than the initial result. Sample ids: (b)(6) were not repeated on the first alternate instrument. Sample id: (b)(6) was not repeated on the second alternate instrument. The customer did not issue corrected reports 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 | 2517506-2017-00322 |
| MDR Report Key | 6441697 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-03 |
| Device Manufacturer Date | 2013-03-14 |
| Date Added to Maude | 2017-03-28 |
| 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 | 2017-03-28 |
| 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 | 2017-03-28 |
| 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 | 2017-03-28 |