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 2017-11-01 for DIMENSION VISTA? K1023 SMN 10445160 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[91333719]
The customer contacted the siemens healthcare diagnostics customer care center about the discordant falsely depressed ca results. The cause of the discordant falsely depressed ca results is unknown. The incident is under investigation by the siemens headquarters support center (hsc).
Patient Sequence No: 1, Text Type: N, H10
[91333720]
Discordant falsely depressed calcium (ca) results were obtained on patient samples on the dimension vista 1500 instrument. The results were reported to the physician(s) who did not question the results. The same samples were repeated on the same instrument with an alternate ca flex reagent cartridge. Higher results were obtained. Corrected reports were issued. There are no known 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 | 2517506-2017-00765 |
| MDR Report Key | 6992761 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-01 |
| Date of Report | 2018-02-09 |
| Date of Event | 2017-10-07 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2017-06-20 |
| Date Added to Maude | 2017-11-01 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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 - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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? |
| Generic Name | DIMENSION VISTA? CA CALCIUM FLEX? REAGENT CARTRIDGE |
| Product Code | CIC |
| Date Received | 2017-11-01 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |