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 2017-01-10 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[64436891]
The customer contacted a siemens customer care center (ccc) specialist. The ccc was granted permission for remote connection. The ccc reviewed the quality control (qc) data. The qc data was in range at the time of the event. The ccc requested the customer to run a three cup precision study using level 2 qc material, resulting out of range. The ccc auto-aligned reagent probes 3 and 4 and sample probe 2. The ccc ran a sodium hydroxide clean on reagent probes 3 and 4. The ccc primed probe pumps 10 times and homed all modules. The instrument was reset. The ccc requested the customer to repeat the 3 cup precision, resulting within range. The cause of the discordant, falsely depressed cholesterol 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
[64436892]
Discordant, falsely depressed cholesterol results were obtained on two patient samples on a dimension vista 1500 instrument. The initial results were reported out to the physician(s). The customer repeated the same samples on an alternate dimension vista instrument, resulting higher. A corrected report was issued to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed cholesterol results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00033 |
| MDR Report Key | 6239348 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-10 |
| Date of Report | 2017-01-10 |
| Date Mfgr Received | 2016-12-16 |
| Device Manufacturer Date | 2014-03-13 |
| Date Added to Maude | 2017-01-10 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION NUMBER: 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 | CHH |
| Date Received | 2017-01-10 |
| 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 | 2017-01-10 |
| 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 | 2017-01-10 |