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 2017-11-08 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[92542068]
The customer contacted the siemens customer care center (ccc) to report the discordant vancomycin result. Quality control (qc) results were within range. The ccc recommended the customer to clean the aliquot probe and drain. The customer cleaned aliquot probe and drain. The ccc primed the system. The ccc ran check 1, which passed. The ccc re-sat the instrument. The customer ran vancomycin precision study with good results. The cause of the discordant vancomycin result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required. Mdr 2517506-2017-00806 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[92542069]
A discordant, vancomycin result was obtained on one patient sample on a dimension vista 1500 (serial (b)(4)) instrument. The sample was also run on an alternate dimension vista instrument (serial (b)(4)), resulting falsely low. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same (serial (b)(4)) and on an alternate (serial (b)(4)) instrument, resulting higher. The correct result obtained on an alternate (serial (b)(4)) instrument, after re-centrifugation, was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant vancomycin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00805 |
| MDR Report Key | 7011582 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-08 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-11-13 |
| Device Manufacturer Date | 2010-05-27 |
| Date Added to Maude | 2017-11-08 |
| 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 | 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 | 2017-11-08 |
| 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 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | DIMENSION VISTA 1500 |
| Product Code | JJE |
| Date Received | 2017-11-08 |
| 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 | 2017-11-08 |