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..
[90157796]
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse replaced the sample 1 mixer and executed auto-mix verification and diagnostics successfully. During a follow-up visit, the cse ran service methods on server 2, which were within range except for bottom of cuvette on sample probe 2 (s2). The cse ran auto alignment for s2 and mixer diagnostic to set the bottom of cuvette correction (bocc), which failed for low current on sample probe 1 (s1). The cse replaced the s1 mixer cable and ran mixer diagnostic test, which failed for no reagent dispensed. The cse ran quick check and check 1 for s1 and s2, diagnostic test and service method for s2 alignment, which passed. The cse calibrated the assays, which failed. The cse ran three known patient samples for troubleshooting purpose, which had unacceptable values. The cse manually adjusted the bocc and performed manual adjustments after which acceptable values were obtained. The cse stated that replacing the s1 printed circuit mixer assembly and correction to s2 bocc resolved the issue. The cause of the discordant, falsely low glu result on patient samples is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[90157797]
Discordant, falsely low glucose (glu) results were obtained on 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 an alternate dimension vista instrument, while it is unknown if the remaining samples were repeated on the same instrument or the alternate instrument. The results for all samples repeated higher. The repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low glu results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00756 |
| MDR Report Key | 6941666 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-11 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-09-19 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2014-10-28 |
| 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 | CFR |
| 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 |