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 2018-02-26 for DIMENSION VISTA? K1061 SMN10445144 manufactured by Siemens Healthcare Diagnostics Inc..
[101155264]
The customer contacted the siemens customer care center (ccc) for the discordant phosphorus (phos) results obtained on the dimension vista instrument. Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant phosphorus (phos) results. Headquarters support center (hsc) has reviewed the information provided as well as a review of instrument data. Based on review of calibration history, the customer calibrated phos using reagent lot 17291ac and used this calibration until (b)(6) 2018 when qc recovery was out of range high. The qc was run using flex sequence 104, well set 6;10;2. The issue was resolved by recalibrating phos using a new flex sequence 103 and well set 5;9;1. The discrepant patients were repeated and corrected reports were issued. After recalibration, the instrument is currently working as specified. No further action will be taken by hsc. No further evaluation of the device is required
Patient Sequence No: 1, Text Type: N, H10
[101155265]
Discordant depressed phosphorus (phos) results were obtained on multiple patient samples on the dimension vista 1500 instrument. The initial results were reported. One patient received treatment based on the discrepant result. The same patient samples were repeated after recalibration of the same flex reagent cartridge with an alternate flex well set higher results were obtained. Corrected reports were issued. There are no reports of patient intervention or adverse health consequences due to the discordant depressed phos results or due to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00102 |
| MDR Report Key | 7297195 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-01-29 |
| Date Mfgr Received | 2018-01-31 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2018-02-26 |
| 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 | 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? PHOSPHORUS FLEX? REAGENT CARTRIDGE |
| Product Code | CEO |
| Date Received | 2018-02-26 |
| Catalog Number | K1061 SMN10445144 |
| Lot Number | 17291AC |
| Device Expiration Date | 2018-10-18 |
| 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 | 2018-02-26 |