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 2017-07-12 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[79951491]
The customer contacted the siemens customer care center (ccc). The customer examined the probes and cleaned sample probe 1 (s1), reagent probe 1 (r1) and reagent probe 2 (r2) drains with drain brush. The customer performed alignments on s1, r1, and r2 which passed. A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse found a cracked sample drain and replaced it. The cse replaced s1 and r1 probes and aligned them. The cse ran service methods, resulting satisfactory. The customer ran qc, resulting satisfactory. A cse was at the customer's site four days later to address the r2 bottom of cuvette alignment and potential sampling issues. The cse ran service methods, resulting satisfactory. The cause for the discordant, falsely low alb result is unknown. Mdr 2517506-2017-00585 was filed for the same event. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[79951492]
A discordant, falsely low albumin (alb) result was obtained on a patient sample on a dimension vista 500 instrument. The discordant result was reported to the physician(s). The sample was repeated on the same instrument, resulting higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low alb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00589 |
| MDR Report Key | 6707827 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2017-07-18 |
| Device Manufacturer Date | 2013-01-30 |
| Date Added to Maude | 2017-07-12 |
| 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 | 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 AVENUE |
| 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | CJW |
| Date Received | 2017-07-12 |
| Model Number | DIMENSION VISTA 500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | JJE |
| Date Received | 2017-07-12 |
| Model Number | DIMENSION VISTA 500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-07-12 |