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 2017-10-26 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[90959422]
The customer contacted the siemens customer care center (ccc). The customer's quality control (qc) was within the acceptable range on the day the event occurred. The repeat testing was run with a new reagent well set after the customer had bumped the old one. A siemens customer service engineer (cse) was dispatched to the customer site. The cse inspected the wells and verified the stamp on the questionable flex. The cse performed verification on the wells by running patient comparison with other dimension vista instruments, resulting within range. The cse ran qc, resulting within range. The reagent lot in question was sent to the technical support laboratory for assessment. Calibration and qc testing met acceptable limits. A patient plasma sample was run in "batch mode", for a total of 600 tests, and no outliers were obtained. The issue could not be confirmed. The cause of the discordant, falsely low ca result 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
[90959423]
A discordant, falsely depressed calcium (ca) result was obtained on a patient sample on a dimension vista 1500 instrument. The discordant result was reported to the physician(s). The sample was repeated on the same instrument, resulting higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ca result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00790 |
| MDR Report Key | 6981518 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-26 |
| Date of Report | 2018-02-09 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2008-09-24 |
| Date Added to Maude | 2017-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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. JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-02/01/2018-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | CJY |
| Date Received | 2017-10-26 |
| 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? |
| Generic Name | DIMENSION VISTA? CA CALCIUM FLEX? REAGENT CARTRIDGE |
| Product Code | CIC |
| Date Received | 2017-10-26 |
| Model Number | DIMENSION VISTA 1500 |
| Catalog Number | K1023 SMN 10445160 |
| Lot Number | 17171BD |
| Device Expiration Date | 2018-06-20 |
| 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 | 2017-10-26 |