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 2016-02-03 for DIMENSION? CLINICAL CHEMISTRY SYSTEM 10444904 RF420 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[37440190]
Analysis of the instrument and instrument data indicate that the cause for the discordant elevated mmb result is unknown. However, the patient sample is suspected to contain an heterophilic antibody. The same patient sample also gave discordant elevated results for troponin i, adding further to the suspicion of patient specific heterophilic antibodies. The account did not perform confirmatory testing and did not provide a sample to siemens healthcare for non-specific binding evaluation. 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 instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[37440191]
A discordant elevated mass creatine kinase (mmb) result was obtained on a patient sample on the dimension rxl max system. The result was questioned within the laboratory. The same sample was retested on an alternate dimension xpand system (same methodology) and an elevated result was also observed. Patient treatment was not altered or prescribed on the basis of the discordant elevated mass creatine kinase (mmb) result. There was no report of adverse health consequences as a result of the discordant elevated mass creatine kinase (mmb) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00006 |
| MDR Report Key | 5408407 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-15 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-01-15 |
| Device Manufacturer Date | 2015-10-20 |
| Date Added to Maude | 2016-02-03 |
| 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 | MEDICAL TECHNOLOGIST |
| 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? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2016-02-03 |
| Model Number | 10444904 |
| Catalog Number | RF420 |
| Lot Number | EB6294 |
| Device Expiration Date | 2016-10-20 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2016-02-03 |