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 2016-11-16 for DIMENSION? RF520 SMN10444895 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[60093560]
Analysis of the instrument and instrument data indicates that the cause for the discordant elevated lmmb result is unknown. However, the siemens headquarters support center evaluated the information made available. The determination was that the elevated mmb value is patient specific, repeatable, and discordant with the cki value. Testing on an alternate instrument system recovers a value within the normal range, congruent with the cki value. This data is consistent with non-specific binding interference. The lmmb 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. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[60093561]
A discordant elevated mass creatine kinase mb isoenzyme (lmmb) result was obtained on a patient sample on the dimension exl instrument. The result was not reported to the physician. The same sample was later repeated at an alternate laboratory on an alternate non-siemens methodology and a lower result was obtained and reported. There is no indication that patient treatment was altered or prescribed on the basis of the discordant elevated lmmb result. There was no report of adverse health consequences as a result of the discordant elevated lmmb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00388 |
| MDR Report Key | 6107586 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-16 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-10-19 |
| Date Mfgr Received | 2016-10-20 |
| Device Manufacturer Date | 2016-08-08 |
| Date Added to Maude | 2016-11-16 |
| 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 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 |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? LMMB MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2016-11-16 |
| Catalog Number | RF520 SMN10444895 |
| Lot Number | FB7220 |
| Device Expiration Date | 2017-08-08 |
| 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 NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-16 |