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 2019-01-09 for DIMENSION? RF420 SMN 10444904 manufactured by Siemens Healthcare Diagnostics Inc.
[132645708]
The customer contacted a siemens customer care center (ccc) for the falsely elevated mass creatine kinase mb isoenzyme (mmb) results. Siemens headquarters support center (hsc) has reviewed the information provided. The review of instrument data files did not indicate any abnormal patterns when compared to other mmb samples, which indicated that the reaction performed as expected, ruling out sampling, instrument, or reagent issues. Quality control was in range. Hsc reviewed patient medications to rule out possible interferences. None of the listed medications for the patient provided to siemens by the customer were indicated in the dimension mmb instructions for use (ifu) listings for assay interference. Siemens requested the patient sample to be returned to perform testing to rule out or confirm non-specific binding (nsb)/heterophile antibody interference. The customer no longer had the patient sample; therefore, confirmation testing could not be performed. 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 with immunoassays to give falsely elevated or depressed results. The dimension exl mmb assay has been designed to minimize interference from heterophilic antibodies, but complete elimination of this interference cannot be guaranteed. " the cause of the discordant mmb results is unknown. No product nonconformance was identified. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[132645709]
Discordant mass creatine kinase mb isoenzyme (mmb) results were obtained on a patient sample on the dimension exl system. The results were not reported. The same sample was reprocessed at an alternate facility on an alternate methodology and a lower result was obtained. There are no known reports of patient intervention or adverse health consequences due to the discordant elevated mmb results. The patient had been sent to the customer hospital for evaluation for myocardial infarction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2019-00007 |
| MDR Report Key | 8232397 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2018-12-19 |
| Device Manufacturer Date | 2018-04-04 |
| Date Added to Maude | 2019-01-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 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 | 2019-01-09 |
| Catalog Number | RF420 SMN 10444904 |
| Lot Number | FA9094 |
| Device Expiration Date | 2019-04-04 |
| 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 |
| Manufacturer Address | 500 GBC DRIVE P.O. BOS 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-09 |