MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-02-07 for DIMENSION VISTA? K6464 SMN 10461743 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[66736810]
Analysis of the information provided by the customer indicates that the cause for the discordant elevated prog result is unknown. A siemens headquarters support center representative evaluated the information and was unable to perform a verification of the discordance relative to alternate methodologies. No sample has been provided to siemens for evaluation. No specific prog lot number has been provided. The customer did not perform any heterophilic interference testing. The prog flex reagent cartridge instructions for use limitations of procedure section 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. No further evaluation of the device is possible due to the time between the incident and the reporting to siemens.
Patient Sequence No: 1, Text Type: N, H10
[66736811]
A discordant elevated progesterone (prog) result was obtained on a patient sample on the dimension vista 1500 instrument. The result was reported to the physician. The same sample was later repeated at an alternate laboratory and run on two alternate non-siemens methodologies. A lower result was obtained on both methodologies. There is no indication that patient treatment was altered or prescribed on the basis of the discordant elevated progesterone (prog) result. There was no report of adverse health consequences as a result of the discordant elevated progesterone (prog) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00095 |
| MDR Report Key | 6308839 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2016-09-13 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-02-07 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? PROG PROGESTERONE FLEX? REAGENT CARTRIDGE |
| Product Code | JLS |
| Date Received | 2017-02-07 |
| Catalog Number | K6464 SMN 10461743 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |