MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for DIMENSION VISTA? K6451 SMN 10445090 manufactured by Siemens Healthcare Diagnostics Inc..
[105399609]
Mdrs 2517506-2018-00220, 2517506-2018-00221, and 2517506-2018-00222 were filed for the same customer inquiry. The customer contacted siemens customer care center (ccc) and reported that a discordant, falsely elevated tpsa patient result was obtained on the dimension vista system. The customer confirmed that there have been no issues with quality control (qc) and all survey results were good. Siemens headquarters support center (hsc) evaluated the information provided by the customer including information the customer provided on results on a later date sample when treated with a heterophile antibody blocking tube. The cause of the discordant, falsely elevated tpsa patient result is unknown. Hsc noted that the results are consistent with a heterophilic antibody interference as indicated in the dimension vista tpsa instructions for use. The dimension vista? Tpsa total prostate specific antigen flex? Reagent cartridge instructions states: patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. The instrument is performing according to specifications. No further evaluation of this instrument is required.
Patient Sequence No: 1, Text Type: N, H10
[105399610]
A discordant, falsely elevated total prostate specific antigen (tpsa) result was obtained on a patient sample on the dimension vista 500 system. This result was reported to the physician. The result was questioned at a later date when a new sample was tested by an alternate non-siemens methodology and a lower result was obtained. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tpsa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00219 |
| MDR Report Key | 7423269 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-11 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2018-03-20 |
| Date Added to Maude | 2018-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? TPSA TOTAL PROSTATE SPECIFIC ANTIGEN FLEX? REAGENT CARTRIDGE |
| Product Code | MTF |
| Date Received | 2018-04-11 |
| Catalog Number | K6451 SMN 10445090 |
| Lot Number | NOT PROVIDED |
| 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 | 2018-04-11 |