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 2017-11-09 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[92620801]
The customer contacted a siemens customer care center (ccc). The customer stated that the process error log showed several aliquot probe bad sample detect errors and clog detect errors. Quality control was within acceptable range. Upon the ccc specialist's recommendations, the customer performed precision testing using level 1 quality control, which was precise. The customer cleaned the aliquot probe, aliquot drain and sample probe 1. The customer then reseated the level sense cable and redistributed grease on the vertical lead screw. The aliquotter was primed and purged. The customer ran check 1, which failed as the air knife pressure was high. The air knife was exercised and check 1 was rerun with no failures. Several patient samples were run before and after the discordant results were obtained with no issues. The customer suspected the issue to be due to the sample. A siemens headquarters support center specialist reviewed the information provided and concluded that the potential cause of the discordant results was due to sample specific issues related to sample integrity or sample handling. The process errors indicated a clogged probe and short sample occurred during the timeframe that the discordant sample was being processed. Aspiration of cellular debris, gel globules and other artifacts from the aliquot well can result in inconsistent sampling and issues with recovery. The customer continued to run samples on the analyzer and has had no other incidents related to this issue. The cause of the discordant, falsely low glucose result on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[92620802]
Discordant, falsely low glucose results were obtained on one patient sample upon initial and repeat testing on a dimension vista 500 instrument. The discordant results were not reported to the physician(s). The sample was repeated on an alternate dimension vista instrument, resulting higher and matching the clinical picture of the patient. The result obtained on the alternate dimension vista instrument was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low glucose result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00813 |
| MDR Report Key | 7014176 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2017-10-12 |
| Device Manufacturer Date | 2014-08-21 |
| Date Added to Maude | 2017-11-09 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| 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 | CFR |
| Date Received | 2017-11-09 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-09 |