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 2017-12-05 for DIMENSION VISTA? K1023 SMN 10445160 manufactured by Siemens Healthcare Diagnostics Inc.
[93823363]
The customer contacted the siemens healthcare diagnostics customer care center about the discordant falsely depressed ca result. The siemens healthcare diagnostics technical solutions laboratory (tsl) and headquarters support center (hsc) conducted further investigation on lot 17171bd calcium (ca) flex reagent cartridges. Headquarters support center (hsc) has confirmed that when using the dimension vista calcium (ca) reagent lot 17171bd, quality control (qc) and patient samples may show decreased recovery of >0. 6 mg/dl (0. 15 mmol/l) within an individual well set. Siemens is continuing to investigate the device issue.
Patient Sequence No: 1, Text Type: N, H10
[93823364]
A discordant falsely depressed calcium (ca) result was obtained on a patient sample on the dimension vista 500 instrument. The result was not reported to the physician. The same sample was repeated on an alternate dimension vista instrument and a higher result was obtained and reported. 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 | 2517506-2017-00833 |
| MDR Report Key | 7084202 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-05 |
| Date of Report | 2018-02-09 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2017-06-20 |
| Date Added to Maude | 2017-12-05 |
| 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 |
| 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 | 2017-12-05 |
| 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 | 2017-12-05 |