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 2018-02-06 for DIMENSION VISTA? K1023 SMN 10445160 manufactured by Siemens Healthcare Diagnostics Inc..
[99788291]
The customer contacted the siemens customer care center (ccc) stating that they had gotten a complaint from a physician in regards to a low calcium (ca) result. The result was low relative to the result obtained with an alternate non-siemens instrument system. The customer noted that quality control (qc) results for the date the sample was run were within acceptable ranges and no proficiency testing failures have occurred. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[99788292]
A discordant falsely depressed calcium (ca) result was obtained on a patient sample on the dimension vista 500 instrument. The result was reported to the physician who questioned the result. The same sample was repeated on an alternate non-siemens instrument system and a higher result was obtained. No corrected report was issued. There is no known report 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 | 2517506-2018-00078 |
| MDR Report Key | 7244055 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-06 |
| Date of Report | 2018-02-22 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2018-02-07 |
| Device Manufacturer Date | 2017-07-26 |
| Date Added to Maude | 2018-02-06 |
| 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 | 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 |
| 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 | 2018-02-06 |
| Catalog Number | K1023 SMN 10445160 |
| Lot Number | 17206BC |
| Device Expiration Date | 2018-07-25 |
| 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 | 2018-02-06 |