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 2017-10-12 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[90238103]
The customer contacted the siemens customer care center (ccc). The customer stated that quality controls (qc) were within the acceptable limits on the day the event occurred. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse replaced sample 1 mixer board and the sample probe. The cse primed the system and ran system check, resulting satisfactory. The cse verified the mixer operation through mixer diagnostics testing, which resulted within ranges. The cause of the discordant, falsely low glu result is unknown. As per the dimension vista operator's guide, a result flagged with an "abnormal assay" cannot be reported. The cause of the flagged result being reported was an operator error. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[90238104]
A discordant, falsely low glucose (glu) result was obtained on a patient sample on a dimension vista 1500 instrument. The discordant result was flagged with "abnormal assay" and was erroneously reported to the physician(s). A nurse questioned the result, as a higher result was obtained on a hand held device. The sample was repeated on an alternate dimension vista instrument, resulting 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 glu result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00764 |
| MDR Report Key | 6945742 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-09-18 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2016-07-14 |
| Date Added to Maude | 2017-10-12 |
| 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 | 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 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | CFR |
| Date Received | 2017-10-12 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 2017-10-12 |