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 2017-03-20 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[70459841]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse verified that test point was not on the same server and ran challenge methods for which all methods resulted within specifications. The cse ran quality controls (qc), resulting within range. The cse and a regional support center (rsc) specialist performed service methods for server 2 and ran process mix tests for sample probe 2 (s2), reagent probe 3 (r3) and reagent probe 4 (r4). All resulted within specifications. The cse cleaned drains and reagent insert covers for r3 and r4 probes. The cse adjusted the pressure cuvette for failing probe test for r3, r4 and s1. The cse performed system check and ran quality controls (qc), resulting within range. The cause for the discordant, falsely elevated tbil results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[70459842]
Discordant, falsely elevated total bilirubin (tbil) results were obtained on patient samples on a dimension vista 1500 instrument. The discordant results were not reported to the physician(s). The samples were repeated on an alternate dimension vista instrument, resulting lower and matching the patients' clinical histories. The repeated results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tbil results.
Patient Sequence No: 1, Text Type: D, B5
[74816788]
The initial mdr 2517506-2017-00278 was filed on march 20, 2017. On 03/07/2017: a siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced serever 2 drains, probes and mixers and auto aligned the probes. The cse performed system check and ran quality control (qc), resulting within range. On 03/09/2017: a siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced mixers, all valves and flush pumps reagent probe 3. On 03/10/2017: the cse did a visual inspection of aliquot probe, drain and probe coating, after which the probe and drain were replaced due to stickiness gel buildup. The cse replaced reagent 3 (r3) metering pump and recalibrated the total bilirubin (tbil). The cse ran quality controls (qc), resulting within range. A siemens headquarter support center (hsc) specialist reviewed the instrument data and concluded the cause of the discordant, falsely elevated tbil results was due to reagent well instability.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00278 |
| MDR Report Key | 6419547 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-20 |
| Date of Report | 2017-04-27 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2017-03-07 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2017-03-20 |
| 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 | MS. 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 | MQM |
| Date Received | 2017-03-20 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-03-20 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-03-20 |