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 2017-03-14 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[69948501]
The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data provided. The customer's quality control (qc) was in at the time of the event. A siemens headquarters support center (hsc) evaluated the event. Hsc found several occurrences of integrated multisensor technology (imt) module : imt bubble errors, aliquot probe : clog detected, in the instrument health report. Hsc found clog detected errors on the day of the event. Hsc stated this method has not been validated for manual dilution of ammonia samples with results that fall below the assay range (<10 umol/l). For samples that recover below assay range dilution with samples of known ammonia concentrations is also not advised. Operator's guide recommend customers refer to the method specific ifu for manual dilution information. The cause of the discordant, falsely depressed ammonia result 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
[69948502]
A discordant, falsely depressed ammonia result was obtained on a patient sample on a dimension vista 500 instrument. The initial result was not released to the physician(s). The customer repeated the same sample on the same dimension vista instrument with a 1:2 dilution, resulting higher. The customer repeated the same sample on the same dimension vista instrument straight, resulting similarly to the initial result. The customer repeated the same sample on the same dimension vista instrument, with dilution (1:2), resulting higher. The customer reported the first repeat result to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ammonia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00266 |
| MDR Report Key | 6405026 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-14 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-02-17 |
| Date Mfgr Received | 2017-02-17 |
| Device Manufacturer Date | 2013-05-22 |
| Date Added to Maude | 2017-03-14 |
| 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2017-03-14 |
| 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 | 2017-03-14 |
| 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 | 2017-03-14 |