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 2017-07-19 for DIMENSION? RF420 SMN 10444904 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[80412922]
The cause of the discordant elevated mmb result is unknown. Customer care center (ccc) analysis of the data shows imprecision as the sample was rerun. Values ranged from just below the assay upper assay range to values greatly above the range. Cki and tni were run on same patient and no issues were reported with the patient results. Quality control was within laboratory range on the date of testing. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[80412923]
A discordant elevated mass creatine kinase mb isoenzyme (mmb) result was obtained on a patient sample on the dimension exl system. The repeated result >600 ng/ml was reported to the physician and not questioned. The same sample was auto-diluted and elevated results were obtained. Manual dilution of the sample (2x and 5x) obtained lower results. There are no known reports of patient intervention or adverse health consequences due to the discordant elevated mmb result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00569 |
| MDR Report Key | 6724346 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-19 |
| Date of Report | 2017-08-16 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2017-04-03 |
| Date Added to Maude | 2017-07-19 |
| 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 | 2017-07-19 |
| Catalog Number | RF420 SMN 10444904 |
| Lot Number | FB8093 |
| Device Expiration Date | 2018-04-03 |
| 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 | 2017-07-19 |