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 2017-10-09 for DIMENSION VISTA 500 DIMENSION VISTA? 500 manufactured by Siemens Healthcare Diagnostics Inc..
[90038922]
The customer contacted the siemens customer care center (ccc) to report the discordant glucose result. The customer stated quality control (qc) results earlier in the day resulted with abnormal assay results. The customer stated they had resolved by resetting result monitors. Ccc educated the customer that the result monitor should not be reset without instructions from siemens technical support. A siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced sample probe 2 (s2), reagent probe 2 (r2) and sample mixer. The cse ran service methods to make necessary adjustments. The cse re-ran service methods to verify corrections, which was acceptable. The cse ran system check and qc, which were acceptable. The cause of the discordant glucose result 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
[90038923]
A discordant, falsely low glucose result was obtained on one patient samples on a dimension vista 500 instrument. The initial result was reported to the physician(s). The sample was repeated on an alternate instrument, and recovered higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low glucose result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00757 |
| MDR Report Key | 6932502 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-09-14 |
| Device Manufacturer Date | 2011-05-11 |
| Date Added to Maude | 2017-10-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | 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 | 2017-10-09 |
| 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 |
| Brand Name | DIMENSION VISTA 500 |
| Generic Name | DIMENSION VISTA 500 |
| Product Code | JJE |
| Date Received | 2017-10-09 |
| 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 | 2017-10-09 |