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 2017-04-13 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[72799735]
A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer. The cse replaced sample 2 probe. The cse aligned reagent 4 probe and sample 2 probe. The cse performed alignments of reagent 4 probe, sample 2 probe and cuvette ring. The cse ensured the system was running as expected by performing comparison studies on different samples, after which resulted within the acceptable ranges. The cse ran quick check and quality control (qc) for server 2, resulting within specifications. The cause of the discordant, falsely elevated tbil 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
[72799736]
Discordant, falsely elevated total bilirubin (tbil) results were obtained on two patient samples on a dimension vista 1500 instrument. The discordant results were not reported to the physician(s). The samples were repeated on the same instrument, resulting lower. It is unknown if the repeated results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tbil results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00382 |
| MDR Report Key | 6490456 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2015-10-06 |
| Date Added to Maude | 2017-04-13 |
| 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 | MS. CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 | MQM |
| Date Received | 2017-04-13 |
| 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 | 2017-04-13 |
| 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 | 2017-04-13 |