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 2016-06-23 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.
[48058949]
A siemens customer service engineer (cse) was dispatched to the customer site. On (b)(4) 2016, the cse performed a total service visit. The cse performed service methods on server 1. The cse ran alignments on reagent probe 1. The cse ran calibration, which passed. The cse ran quality controls (qc), which were within range. On (b)(4) 2016, the cse revisited the customer site to replace parts. The cse replaced reagent probe mixers and printed circuit board assembly. The cse ran alignment and mix test, which passed. On (b)(4) 2016, the cse revisited the customer site and performed total service visit. The cse ran service methods and ran align test for reagent probe 2. The cse ran patient samples in duplicates, and all calcium results were within acceptable range. On (b)(4) 2016, the cse returned to the customer site to replace parts. The cse checked the vacuum, replaced and aligned aliquot probe and replaced the aliquot pump. The cse ran a quick check, which passed. The cse ran qc, which were within range. A siemens regional support center (rsc) specialist reviewed the instrument data. The rsc specialist discovered that there was water temperature instability with the instrument's water purification module. The copper lines were found warm and incoming water temperature was above the expected range. The vent tubing was removed, after which temperature became more stable. Rsc requested that the customer check with their facilities the source of the warm water coming in, find out the backpressure and if the ceiling is able to properly vent. On (b)(4) 2016, the cse revisited the customer site and replaced heat exchanger fan, water mixer, sample probe 1 (s1) and integrated multi-sensor technology (imt) gaskets. The cse ran a quick check, which passed. The cse ran qc, which were within range. On follow up visits, the ca method was moved to server 3 and then back to server 1. On (b)(4) 2016, the cse revisited the customer site and replaced s1 mixer, heat exchanger fan and filter and blending valve. The cse ran multiple patients samples, all resulting within acceptable range. The cause of the discordant ca results on patient samples 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
[48058950]
A discordant, falsely depressed calcium (ca) result was obtained on one patient sample (sample id (b)(6)) on a dimension vista 1500 instrument ((b)(4)). The discordant result was not reported to the physician(s). The sample was repeated on the same instrument and on an alternate instrument ((b)(4)), resulting higher. The corrected result obtained on the alternate instrument was reported to the physician(s). On (b)(6) 2016, the customer called back to report an additional falsely low ca result obtained on a patient sample two days prior. The sample was repeated on the same instrument and on alternate instrument, resulting higher. It is unknown if any of these results were reported to the physician(s). On (b)(6) 2016, the customer obtained additional discordant ca results on two patient samples. The discordant results were not reported to the physician(s), as the customer has been running in duplicate. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ca results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00340 |
| MDR Report Key | 5745282 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-23 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-06-01 |
| Device Manufacturer Date | 2011-12-21 |
| Date Added to Maude | 2016-06-23 |
| 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 AVE |
| 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 |
| 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 | CIA |
| Date Received | 2016-06-23 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-23 |