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 2017-03-01 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[68773261]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated they found a sample with a failed delta check and repeat did not match. The ccc was granted permission to dial in remotely. A review of the quality control (qc) showed it was in range at the time of the event. The ccc performed a check 1 on reagent probe 1, which failed for drain/vacuum pairs. Ccc repeated this, which failed. The ccc ran a check 1 on reagent probe 2, resulting within specifications. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse ran server 2 service methods, resulting in range. The cse replaced server 2 drains. The cse ran a check vacuum, which failed. The cse adjusted all drains vacuum values. The cse performed diagnostic and checks, resulting in range. The cse ran a quick check and qc, resulting in range. The customer ran service method testing (smt), resulting in range. Customer ran overmix and alignment, resulting in range. The cse replaced the drains and adjusted the vacuum. The cse reviewed the instrument. The cse found sample probe 2, reagent probe 3 and reagent probe 4 alignment was within range. Reagent probe 3 mixer, sample 2 probe mixer, overmix and service methods were ran, all resulting within range and specifications. The cse ran all air knifes, resulting within range. Total bilirubin was calibrated and precision was ran, resulting within range. Siemens in investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[68773262]
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 the same instrument, resulting lower. The customer reported out the repeat result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00218 |
| MDR Report Key | 6371083 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-02-04 |
| Date Mfgr Received | 2017-02-04 |
| Device Manufacturer Date | 2015-07-30 |
| Date Added to Maude | 2017-03-01 |
| 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 | 2017-03-01 |
| 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 | 2017-03-01 |
| 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 | 2017-03-01 |