MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-04 for DIMENSION? CLINICAL CHEMISTRY SYSTEM RF420 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[17612850]
A customer observed biased low mass creatinine kinase mb isoenzyme (mmb) results on patient crossover and qc samples on lot ed5167 reagent cartridges. No patient results were reported to physicians. Patient treatment was not altered or prescribed on the basis of the biased low mmb results. There was no report of adverse health consequences as a result of the biased low mmb results.
Patient Sequence No: 1, Text Type: D, B5
[17808969]
The cause of the biased low mass creatinine kinase mb isoenzyme (mmb) results is lot to lot variability of the mass creatine kinase mb isoenzyme flex? Reagent cartridge. The issue was resolved by the customer with recalibration which provided better correlation to the customer's alternate dimension instrument. Siemens healthcare technical service laboratory conducted an investigation of lot ed5167 and did not confirm the customer's complaint for lot to lot variability. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2014-00184 |
| MDR Report Key | 4059622 |
| Report Source | 05,06 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-08-06 |
| Date Mfgr Received | 2014-08-06 |
| Device Manufacturer Date | 2014-06-16 |
| Date Added to Maude | 2014-09-18 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2014-09-04 |
| Catalog Number | RF420 |
| Lot Number | ED5167 |
| Device Expiration Date | 2015-06-16 |
| 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 | 2014-09-04 |