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 2017-01-10 for DIMENSION? RF420 SMN10444904 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[64368047]
Analysis of the information provided indicate that the cause for the discordant elevated mmb result is unknown. The siemens healthcare diagnostics headquarters support center representative evaluated the information and concluded that the elevated mmb values that are repeatable, discordant with other cardiac values and the clinical impression, and which recover lower values on an alternate method that are congruent with other cardiac values and the clinical impression, are consistent with a patient/method specific interference such as non-specific binding interference. The instructions for use for the mass creatine kinase mb isoenzyme 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. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[64368048]
Discordant, elevated mass creatine kinase (mmb) results were obtained on a patient's sample on the dimension exl 200 system. The results were not reported to the physician. The same sample was retested and repeated and discordant elevated results were obtained. The same sample was retested at an alternate facility and lower results were obtained. Patient treatment was not altered or prescribed on the basis of the discordant elevated mass creatine kinase (mmb) results. There are no reports of patient intervention or adverse health consequences due to the discordant elevated mass creatine kinase (mmb) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00029 |
| MDR Report Key | 6237691 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-10 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2016-12-19 |
| Device Manufacturer Date | 2016-08-17 |
| Date Added to Maude | 2017-01-10 |
| 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 | 2017-01-10 |
| Catalog Number | RF420 SMN10444904 |
| Lot Number | FC7229 |
| Device Expiration Date | 2017-08-17 |
| 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 | 2017-01-10 |