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 2017-11-27 for DIMENSION? RF420 SMN10444904 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[93301028]
Mdr 2517506-2017-00840 was also filed for the same customer inquiry. Quality control was within laboratory range on the date of testing. The ifu for dimension vista? Ctni flex? Reagent cartridge contains the following information: "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 cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. " siemens headquarters support center (hsc) has concluded their investigation with root cause unknown. There is no indication of a product issue. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[93301029]
A discordant elevated mass creatine kinase mb isoenzyme (mmb) result was obtained on a patient sample on the dimension exl system. The result was reported to the physician and not questioned. A 1:3 dilution performed on the third specimen obtained lower results when repeated; however was still elevated. The sample was tested on an alternate methodology on a non-siemens instrument and a lower result was obtained. The customer did not know what alternate methodology or instrument was used when the sample was sent out for testing. No treatment was provided to the patient on the basis of the reported discordant result. There are no known reports of patient intervention or adverse health consequences due to the discordant elevated mmb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00841 |
| MDR Report Key | 7061860 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2017-06-19 |
| Date Added to Maude | 2017-11-27 |
| 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? |
| Generic Name | DIMENSION? MMB MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2017-11-27 |
| Catalog Number | RF420 SMN10444904 |
| Lot Number | FB8170 |
| Device Expiration Date | 2018-06-19 |
| 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 | 2017-11-27 |