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 2017-10-11 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[90159017]
The customer contacted a siemens customer care center. Quality controls and precision runs were acceptable. A siemens customer service engineer (cse) was dispatched to the customer site. The customer stated that they were getting sample cups missing inside the instrument. After analyzing the instrument, the cse verified the alignments and found that the aliquot probe was damaged. The cse replaced the aliquot probe and performed aliquot and shuttle 2 auto alignments. The cse ran check 1 and quality control, which passed. A siemens headquarters support center (hsc) specialist reviewed the instrument data and determined that the instrument was picking up sample cups from the sample racks with the aliquot probe. A different patient sample (sample id (b)(6)) was run prior, while another patient sample ((b)(6)) was run after sample id (b)(6) was processed. Sample ids (b)(6) were flagged with abnormal assay due to the non-specific binding monitor being out of range. The non-specific binding monitor checks for aggregation when particles and samples are present without antibody. Sample ids (b)(6) were suspected for their quality, which can affect subsequent samples. The hsc specialist concluded that even though the sample handling specifics were not provided, the potential cause of the discordant result on one patient sample may have been due to either the issue with aliquot probe or a pre-analytical variable. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[90159018]
A discordant, falsely low vancomycin result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on two alternate dimension vista instruments, resulting higher. The corrected result from one of the alternate dimension vista instruments was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low vancomycin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00731 |
| MDR Report Key | 6941678 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-11 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-09-17 |
| Date Mfgr Received | 2017-09-17 |
| Device Manufacturer Date | 2017-04-03 |
| Date Added to Maude | 2017-10-11 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| 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 | LEH |
| Date Received | 2017-10-11 |
| 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 | 2017-10-11 |