MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-03-18 for CLINICAL CHEMISTRY IRON 7D68-20 manufactured by Abbott Laboratories, Inc..
[808780]
The account generated a depressed architect c8000 iron result on a pt that did not correlate with other methods. The pt tested architect c8000 iron = 7 ug/dl, roche method = 42 ug/dl and kovalente method = 40 ug/dl. The depressed architect c8000 iron result was not reported outside of the laboratory. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[7948200]
Investigation in process, no results or conclusion can be drawn. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2008-00031 |
| MDR Report Key | 1016481 |
| Report Source | 01,05 |
| Date Received | 2008-03-18 |
| Date of Report | 2008-02-21 |
| Date of Event | 2008-02-13 |
| Date Mfgr Received | 2008-02-21 |
| Date Added to Maude | 2009-10-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDARSHAN HEBBAR, MD, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY IRON |
| Generic Name | QUANTITATION OF IRON |
| Product Code | CFM |
| Date Received | 2008-03-18 |
| Model Number | NA |
| Catalog Number | 7D68-20 |
| Lot Number | 56055HW00 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-18 |