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 2017-10-05 for DIMENSION VISTA 500 DIMENSION VISTA? 500 manufactured by Siemens Healthcare Diagnostics Inc..
[88413248]
The customer contacted the siemens customer care center (ccc) to report the discordant glucose results. Quality control (qc) for glucose was within range. The ccc specialist dialed into the system remotely and reviewed the error logs and did not find any issue. The ccc ran the service method testing (smt) and found that the reagent 2 (r2) bottom of cuvette (boc) alignment was out of range. A siemens customer service engineer (cse) was dispatched to the customer site. Qc was within specification. The cse ran server 1 methods and found that the alignments, mixing and metering methods were within specifications. The cse ran blood urea nitrogen and creatinine, which were acceptable. During a follow-up visit the cse replaced the aliquot drain. The cse verified alignment, and ran quick check, qc and precision testing, which were acceptable. The cause of the discordant glucose results is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required
Patient Sequence No: 1, Text Type: N, H10
[88413249]
Discordant falsely low glucose results were obtained on two patient samples on a dimension vista 500 instrument. The initial results were not reported to the physician(s). The samples were repeated on the same instrument, and recovered higher. The repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low glucose results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00750 |
| MDR Report Key | 6918795 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-05 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Device Manufacturer Date | 2011-09-23 |
| Date Added to Maude | 2017-10-05 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD REGISTRATION # : 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 500 |
| Generic Name | DIMENSION VISTA 500 |
| Product Code | CFR |
| Date Received | 2017-10-05 |
| 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 | DIMENSION VISTA 500 |
| Product Code | JJE |
| Date Received | 2017-10-05 |
| 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 | 2017-10-05 |