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 2017-03-31 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[71493574]
The customer contacted a siemens customer care center (ccc). The customer stated that they ran quality controls and one of the replicates out of the multiple replicates was out of range. They repeated the quality control run and results were acceptable. The ccc specialist dialed into the customer's system remotely. The ccc specialist cleaned and aligned the server probes and ran a quick check, which passed. The ccc specialist also performed service method testing, which was failing. A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse found that the reagent 4 arm (r4) mix results were out of specifications. The cse repaired the r4 mixer and arm and performed service method testing. The cse also performed precision testing, which was acceptable. A siemens headquarters support center specialist reviewed the instrument data and service report. The hsc specialist determined that the cause of the discordant, falsely low ucfp results on three patient samples was due to the faulty r4 mixer and arm. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[71493615]
Discordant, falsely low urinary cerebrospinal fluid protein (ucfp) results were obtained on three patient samples on a dimension vista 1500 instrument. The discordant results were not reported to the physician(s). Sample ids (b)(6) were repeated on the same instrument, resulting higher. Sample ids (b)(6) were repeated on an alternate dimension vista instrument, resulting higher. The repeat results from the original instrument were reported for sample ids (b)(6), while a result obtained from the alternate dimension vista instrument was reported for sample id (b)(6). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ucfp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00319 |
| MDR Report Key | 6449424 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-31 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-03-07 |
| Device Manufacturer Date | 2013-01-24 |
| Date Added to Maude | 2017-03-31 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 | JGQ |
| Date Received | 2017-03-31 |
| 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 | 2017-03-31 |
| 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 | 2017-03-31 |