MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-08-27 for DIMENSION RXL CLINICAL CHEMISTRY ANALYZER RF420 manufactured by Dade Behring, Inc..
[211320]
Customer processed a pt sample for ctni (troponin) and mmb (mass creatine kinase mb isoenzyme) on the dimension(r) rxl. Innaccurate low results were obtained due to plasma being removed from the primary tube after instrument performed level sense. There were no adverse pt consequences. Sequence of events: initial sample: instrument correctly performed level sense on primary tube, sample processed from primary tube, results above assay range, auto-dilute initiated, plasma removed from tube by tech (in conclict with instructions provided in the dimension(r) rxl operator guide date 9/00). No results reported. Auto-dilute sample: sample processes from primary tube, insufficient sample due to plasma being removed by tech, low results reported (ctni 0. 00 ng/ml, mmb 0. 60 ng/ml). Restest sample: sample processed from sample cup, manual dilution. (ctni 75. 02 ng/ml, mmb 190. 42 ng/ml).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2001-00031 |
| MDR Report Key | 349799 |
| Report Source | 05,06 |
| Date Received | 2001-08-27 |
| Date of Report | 2001-08-14 |
| Date of Event | 2001-07-29 |
| Date Mfgr Received | 2001-07-29 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2001-09-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ELAINE KINDELL |
| Manufacturer Street | P.O. BOX 6101, MS 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026316564 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION RXL CLINICAL CHEMISTRY ANALYZER |
| Generic Name | MMB FLEX REAGENT CARTRIDGES |
| Product Code | JHY |
| Date Received | 2001-08-27 |
| Model Number | NA |
| Catalog Number | RF420 |
| Lot Number | DD2144 (MMB) |
| ID Number | NA |
| Device Expiration Date | 2002-05-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339108 |
| Manufacturer | DADE BEHRING, INC. |
| Manufacturer Address | P.O. BOX 6101 NEWARK DE 197146101 US |
| Baseline Brand Name | DIMENSION MASS CREATINE KINASE ISOENZYME FLEX |
| Baseline Generic Name | DIMENSION MMB |
| Baseline Model No | NA |
| Baseline Catalog No | RF420 |
| Baseline ID | NA |
| Baseline Device Family | DIMENSION MASS CREATINE KINASE ISOENZYME TEST |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 10 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K970343 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-27 |