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 2017-08-02 for DIMENSION VISTA1500 manufactured by Siemens Healthcare Diagnostics Inc..
[81856507]
The customer contacted the siemens technical support center (tsc) to report the discordant carbon dioxide (co2) results. The customer ran quality control (qc), which was low. The customer tried to align server 2 probes. The customer found that the reagent probe 4 (r4) was failing alignment. The tsc asked the customer to inspect the r4 and, the probe was straight. The customer reseated the probe, cleaned the bearing rails and found the r4 still failing. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse aligned the r4 arm repeatedly but it failed at baseplate. The cse replaced vertical and horizontal belts and horizontal motor, aligned r4 again, which passed. The cse brought analyzer back up and ran server 2 service methods (svmts). The cse found that the sample probe 2 (s2) mixer is not mixing. The cse disabled server 2 and moved co2 to server 3. The cse replaced s2 mixer. The cse ran svmts, mixer diagnostic test, check1 and quality control (qc), which passed. A siemens headquarter support center (hsc) specialist evaluated the data related to the event. Hsc concludes the cause of the issue is due to a failing sample mixer for server 2 that was resolved with replacement of the sample mixer on server 2. The cause of the discordant carbon dioxide results is due to failing sample mixer. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[81856508]
Discordant, falsely low carbon dioxide (co2) results were obtained on nine patient samples on a dimension vista 1500 instrument. The discordant results were reported to the physician(s), who questioned them. The same samples were repeated on an alternate 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 co2 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00620 |
| MDR Report Key | 6761675 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-07-08 |
| Date Mfgr Received | 2017-07-08 |
| Device Manufacturer Date | 2011-11-28 |
| Date Added to Maude | 2017-08-02 |
| 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 AVENUE |
| 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 NUMBER: 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 VISTA1500 |
| Generic Name | DIMENSION VISTA1500 |
| Product Code | CHS |
| Date Received | 2017-08-02 |
| Model Number | DIMENSION VISTA1500 |
| 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 VISTA1500 |
| Generic Name | DIMENSION VISTA1500 |
| Product Code | JJE |
| Date Received | 2017-08-02 |
| Model Number | DIMENSION VISTA1500 |
| 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 | 2017-08-02 |