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 2017-11-07 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[92328816]
The customer contacted the siemens customer care center (ccc) to report the discordant falsely low vancomycin result. The ccc reviewed instrument data and found aliquot probe false transition errors and clog detects errors. Quality control (qc) results were within range. The customer ran a precision study and results were acceptable. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse replaced sample probe 1, as replacement was due. The cse performed alignment and priming. The cse ran quick check, which passed. The cse performed precision run on vancomycin sample, which was acceptable. The customer ran qc, which was acceptable. The cause of the discordant falsely low vancomycin result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[92328818]
A discordant, falsely low vancomycin result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the pharmacist, who questioned it. The sample was repeated on the same instrument, resulting higher. The correct result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low vancomycin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00809 |
| MDR Report Key | 7007857 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-07 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2013-10-14 |
| Date Added to Maude | 2017-11-07 |
| 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 | 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 | 101 SILVERMINE ROAD REGISTRATION NUMBER: 1226181 |
| 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 | DIMENSION VISTA 1500 |
| Product Code | LEH |
| Date Received | 2017-11-07 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-11-07 |