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 2017-04-19 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[73259134]
The customer contacted the siemens technical support center (tsc). A day prior to the event, a siemens customer engineer (cse) was at the customer site for the water purification module (wpm) maintenance. While evaluating the instrument, the cse replaced the reverse osmosis membrane after which, quality control (qc) resulted high. The customer recalibrated the triglycerides method and qc resulted within range, however, it dropped low out of range a few hours later. The tsc explained to the customer this was likely due to glycerol contamination and instructed the customer to flush the water purification module (wpm) tank twice, rerun all qc and recalibrate the triglycerides method, after which both resulted within range. Then the tsc instructed the customer to run the patients' samples, which resulted as expected. The cause of the discordant, falsely high trig results is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[73259135]
Discordant, falsely elevated triglycerides (trig) results were obtained on three (3) patient samples on a dimension vista 500 instrument. The discordant results were reported to the physician(s). The samples were repeated on the same instrument after troubleshooting, resulting lower and matching the patient's clinical picture. The corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated trig results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00410 |
| MDR Report Key | 6503074 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-03-25 |
| Date Mfgr Received | 2017-03-25 |
| Device Manufacturer Date | 2012-11-15 |
| Date Added to Maude | 2017-04-19 |
| 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. 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 | 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | JGY |
| Date Received | 2017-04-19 |
| Model Number | DIMENSION VISTA 500 |
| 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | JJE |
| Date Received | 2017-04-19 |
| Model Number | DIMENSION VISTA 500 |
| 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 | 2017-04-19 |