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 2017-02-28 for DIMENSION? RF420 SMN 10444904 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[68601646]
Analysis of the information provided indicates that the cause for the discordant low mmb serum result is unknown (relative to the higher plasma result regarded by the customer as correct). A siemens healthcare diagnostics headquarters support center (hsc) representative evaluated the information provided. The account did not perform any testing at alternate laboratories or with alternate methodologies. No sample was provided to siemens for evaluation. The mmb values were repeatable and discordant with the normal reference range creatine kinase. The customer stated the discrepancy between serum and plasma values was specific to this individual patient and that no other patients exhibited a similar difference between serum and plasma results. There was no indication of an instrument or reagent malfunction. 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 device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[68601647]
A low result was questioned as discordant for mass creatine kinase mb isoenzyme (mmb) results on a patient's serum samples on the dimension exl system. The serum results were not reported to the physician. The plasma samples on the same patient were tested on the same instrument and higher results were obtained and reported. The higher plasma result was considered correct by the customer. There are no known reports of patient intervention or adverse health consequences due to the questioned, discordant low serum mmb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00136 |
| MDR Report Key | 6367209 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-28 |
| Date of Report | 2017-02-28 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-02-01 |
| Device Manufacturer Date | 2016-08-17 |
| Date Added to Maude | 2017-02-28 |
| 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? MMB MASS CREATINE KINASE MB ISOENZYME FLEX? REAGENT CARTRIDGE |
| Product Code | JHY |
| Date Received | 2017-02-28 |
| Catalog Number | RF420 SMN 10444904 |
| Lot Number | FC7229 |
| Device Expiration Date | 2017-08-17 |
| 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 PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-28 |