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 2017-09-13 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[86135189]
The customer contacted the siemens customer care center (ccc). A ccc specialist reviewed the instrument data and found no reagent or instrument issues associated with this event. Quality control (qc) was within range on the day the event occurred. The ccc had performed diagnostic troubleshooting, which passed. The customer ran precision, resulting within specifications. A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse cleaned the aliquot probe, reinstalled and aligned it. A siemens headquarters support center (hsc) specialist has reviewed the instrument data which indicated there was no issue related to a reagent non-conformance or instrument malfunction. Hsc has concluded that this issue is an isolated event specific to sample handling and or sample integrity. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[86135190]
A discordant, falsely low glucose (glu) result was obtained on a patient sample on a dimension vista 1500 instrument. The discordant result was reported to a nurse(s) who questioned it. The patient was redrawn and the test was repeated via a handheld device, resulting higher. The original sample was then repeated twice, on the same dimension vista instrument, resulting higher than the initial result and matching the patient's clinical picture. The first of the replicate results 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 | 2517506-2017-00703 |
| MDR Report Key | 6863308 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-13 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-08-20 |
| Date Mfgr Received | 2017-08-20 |
| Device Manufacturer Date | 2017-01-28 |
| Date Added to Maude | 2017-09-13 |
| 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 | 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 | 2017-09-13 |
| 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 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | JJE |
| Date Received | 2017-09-13 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 2017-09-13 |