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 2017-10-24 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[90805393]
The customer contacted the siemens customer care center (ccc). Quality controls (qc) were within range on the day of event. Ccc ran service method testing, which passed. A siemens customer service engineer was dispatched to the customer site. The cse determined the cause of the event is consistent with a sample integrity issue which can be caused by pre-analytical factors such as sample tube mixing issues, centrifuge modification speed and time and sample handling issues. The cse ran service method testing for server 1 (s1) mixer and reagent probe 2 (r2) which failed. The cse replaced s1 mixer and auto align r2. The cse ran quality control (qc) which passed. A siemens headquarters support center (hsc) specialist reviewed the instrument data and found no systematic issue and concluded that fibrin or cellular debris, pulled into the aliquot well and probe, may have caused an issue when the sample was being processed. The cause of the discordant, falsely low vancomycin result on one patient sample is unknown. The cause of the sample being centrifuged outside of tube vendor specifications is failure to follow instructions. The instrument is performing according to specifications. No further evaluation of the device is required. Mdr 2517506-2017-00779 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[90805394]
A discordant, falsely low vancomycin (vanc) result was obtained on a dimension vista 1500 instrument ((b)(4)). The result was reported and a pharmacist questioned it. The sample was repeated on the same instrument and two alternate instruments ((b)(4)), resulting higher. The repeat result from the original instrument ((b)(4)) was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low vanc result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00783 |
| MDR Report Key | 6974206 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-24 |
| Date of Report | 2018-02-09 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2018-02-05 |
| Device Manufacturer Date | 2017-03-27 |
| Date Added to Maude | 2017-10-24 |
| 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. 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 | LEH |
| Date Received | 2017-10-24 |
| 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 | 2017-10-24 |