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 2017-09-21 for DIMENSION? DF306 SMN 10464331 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[87375079]
The customer contacted the siemens healthcare diagnostics customer care center to inquire about higher sirolimus results obtained on the dimension exl compared to lower results obtained with an alternate, non-siemens methodology, lcmsms. The siemens headquarters support center (hsc) representative evaluated the information provided. The cause of the higher sirolimus results obtained with the dimension siro flex reagent cartridge is unknown. Hsc determined that the customer did not establish therapeutic ranges for their dimension? Exl but rather transferred ranges from the lc msms assay contrary to instructions in the siro ifu. Due to differences in cross-reactivity with metabolites, sirolimus measurements from different methods cannot be used interchangeably as stated in the sirolimus assay instructions for use. The sirolimus flex reagent cartridge instructions for use cautions: "the optimal concentration range for sirolimus in whole blood using this assay has not been established. Optimal concentration ranges vary according to the specific assay used, and therefore should be established for each specific assay. Values obtained with different assay methods should not be used interchangeably due to differences in cross-reactivity with metabolites, nor should correction factors be applied. Laboratories should include identification of the assay used in order to aid in interpretation of results. Each institution should establish the optimal ranges based on the specific assay used and other factors relevant to their patient population. Optimal ranges depend upon the patient's clinical state, individual differences in sensitivity to immunosuppressive and nephrotoxic effects of sirolimus, co-administration of other immunosuppressants, time post transplant and a number of other factors. Therefore, individual sirolimus values cannot be used as the sole indicator for making changes in treatment regimen and each patient should be thoroughly evaluated clinically before changes in treatment regimens are made. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[87375080]
A discordant elevated sirolimus result (siro) was obtained on a patient sample on the dimension exl system. The result was reported to the physician. The same sample was tested at an alternate laboratory on a non-siemens system and a lower result was obtained. There was no report of adverse health consequences as a result of the discordant elevated dimension siro result on the dimension exl.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00690 |
| MDR Report Key | 6883969 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-21 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2017-02-06 |
| Date Added to Maude | 2017-09-21 |
| 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? SIRO SIROLIMUS FLEX? REAGENT CARTRIDGE |
| Product Code | NRP |
| Date Received | 2017-09-21 |
| Catalog Number | DF306 SMN 10464331 |
| Lot Number | FA8037 |
| Device Expiration Date | 2018-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-09-21 |