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 2017-10-12 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[90237726]
The customer contacted the siemens customer care center (ccc). Ccc performed troubleshooting with the customer on the instrument and probe test on reagent 1 (r1), which failed for air pressure. The ccc primed the probe and ran auto alignment. Probe test failed for air pressure again. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse replaced r1 and tightened all connections and ran diagnostic tests, which passed. The cse performed loci channel photomultiplier tube test which failed. The cse replaced the chamber insert. The cse replaced sample probe 1 (s1) and s1 mixer. Then the cse ran diagnostic tests which passed. The cse ran qc, resulting within range. The cause of the discordant, falsely low glu 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
[90237727]
Discordant, falsely low glucose (glu) results were obtained on patient samples on a dimension vista 1500 instrument. The discordant results were reported to the physician(s) who questioned them. The samples were repeated on an alternate dimension vista instrument, resulting higher and as expected. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low glu results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00763 |
| MDR Report Key | 6945745 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-09-16 |
| Device Manufacturer Date | 2016-07-14 |
| Date Added to Maude | 2017-10-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. 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 | REGISTRATION #: 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 | CFR |
| Date Received | 2017-10-12 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-12 |