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 2016-09-01 for DIMENSION VISTA? SYSTEM K3085 SMN10445135 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[53702600]
Internal investigation confirmed that the 250 ng/dl listed in the instructions for use is not clinically relevant. Testing was conducted at the more clinically relevant concentration of 250 mg/dl confirming that there is interference at a 250 mg/dl concentration of deferoxamine when tested using the dimension vista iron and dimension iron assays. Siemens has issued a urgent medical device correction communication, vc-16-07. A. Us and urgent field safety notice vc-16-07. A. Ous to accounts that have been shipped dimension vista iron k3085 and dimension iron df85 flex reagent cartridges to notify them of the issue. The communication stated that siemens healthcare diagnostics has become aware of deferoxamine interference with dimension and dimension vista iron assays at a different concentration than listed in the instructions for use (ifu). Deferoxamine is listed in the dimension and dimension vista ifu's as a non-interfering substance. The concentration that was used for interference testing (250 ng/dl or 3. 8 nmol/l) is significantly below what would be expected in clinical practice. Via the communications, siemens healthcare diagnostics provided an update to the limitation of procedure section for the dimension and dimension vista iron assays instructions for use (ifu) to indicate that: patients treated with metal-binding drugs (e. G. Deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. The reference to deferoxamine at a concentration of 250 ng/dl (3. 8 nmol/l) will be removed from the non interfering substances section of the ifu's. The information provided in this communication, related to deferoxamine, supersedes the information related to deferoxamine in the current iron ifu's for dimension and dimension vista products until the ifu's are updated.
Patient Sequence No: 1, Text Type: N, H10
[53702601]
A physician questioned the siemens dimension vista iron flex reagent cartridge instructions for use (ifu) relative to the non-interfering substance values provided for the drug, deferoxamine. The physician questioned why the level shown in the ifu (250 ng/dl or 3. 8 nmol/l) was chosen. The physician regarded that level as not clinically meaningful. There was no indication that patient treatment was altered or prescribed on the basis of the information on deferoxamine in the ifu. There was no report of adverse health consequences as a result of the information on deferoxamine in the ifu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00322 |
| MDR Report Key | 5920784 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-01 |
| Date of Report | 2016-09-01 |
| Date of Event | 2016-02-07 |
| Date Mfgr Received | 2016-08-25 |
| Date Added to Maude | 2016-09-01 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? SYSTEM |
| Generic Name | IRON FLEX? REAGENT CARTRIDGE |
| Product Code | JIY |
| Date Received | 2016-09-01 |
| Catalog Number | K3085 SMN10445135 |
| Lot Number | NOT PROVIDED |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-09-01 |