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 2017-10-25 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[90905006]
The customer contacted the siemens customer care center (ccc). Quality controls (qc) were within range on the day the event occurred. Ccc reviewed the data and noted multiple reagent probe 1(r1) flush pump errors were obtained. Ccc instructed the customer to manually titrate the r1 flush pump. The customer titrated the flush pump and obtained a loud squeaking noise. A siemens customer service engineer was dispatched to the customer site. While analyzing the instrument, the cse replaced flush pumps, solenoid valves and air knife. The cse primed the system and ran system check, which passed. The customer then ran qc, resulting within the expected ranges. The cause of the discordant, falsely low vancomycin result on one patient sample 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
[90905007]
A discordant, falsely low vancomycin (vanc) result was obtained on a dimension vista 1500 instrument. The result was reported and a healthcare practitioner questioned it. A new sample was drawn from the patient and tested, resulting higher and matching the patient's clinical history. Then the original sample was repeated on the same instrument and the result was consistent with the new draw result. The corrected result from the new draw sample was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low vanc result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00791 |
| MDR Report Key | 6978691 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-25 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-09-30 |
| Date Mfgr Received | 2017-09-30 |
| Device Manufacturer Date | 2013-11-14 |
| Date Added to Maude | 2017-10-25 |
| 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. 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 | 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 | 2017-10-25 |
| 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 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | JJE |
| Date Received | 2017-10-25 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 2017-10-25 |