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 2017-06-23 for DIMENSION VISTA1500 manufactured by Siemens Healthcare Diagnostics Inc..
[78274145]
The customer contacted the siemens technical support center (tsc) to report the discordant total bilirubin (tbil) result. A siemens customer service engineer (cse) was dispatched to the customer site. The cse ran total bilirubin samples, all in range. The cse checked vacuum and air knife, it was good. The cse changed sample arm 2 (s2), reagent arm 3 (r3), and reagent arm 4 (r4) probes. The cse ran alignments, ran quick check and passed, ran service methods. The cse found that failed alignment test on r3 and r4. The cse realigned until r3 and r4 passed alignment test. The cse performed quality control (qc), all results in range. The cse verified performance of the instrument and noticed pitting on reagent prep probe. The cse replaced probe and cleaned reagent prep probe drain. The cse checked and cleaned reagent probe 3 (rp3) and reagent probe 4 (rp4) flex covers and drains. The cse ran a successful quick check and quality control (qc). The cse ran replicates of tbil qc and precision was exact. The cause of the discordant total bilirubin result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[78274146]
A discordant, total bilirubin result was obtained on one patient sample on a dimension vista 1500 instrument. The initial result obtained on another dimension vista instrument (dv311185) was reported to the physician(s). The sample was then repeated on this instrument an on the alternate dimension vista instrument, resulting lower. The repeat result was not reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant total bilirubin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00538 |
| MDR Report Key | 6663259 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-05-29 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2013-08-28 |
| Date Added to Maude | 2017-06-23 |
| 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 | MQM |
| Date Received | 2017-06-23 |
| 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 | 2017-06-23 |
| 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 | 2017-06-23 |