MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-11-16 for CLINICAL CHEMISTRY IRON 7D68-30 manufactured by Abbott Manufacturing, Inc..
[758154]
The customer states that results from the architect c8000 iron assay do not correlate with pts' clinical conditions and are being questioned by physicians. Also, the c8000 results do not correlate with another mfr's method. Patient #1 generated an architect c8000 iron results of 1. 77 umol/l that retested at 11. 94 umol/l by the other mfr's method. Controls have remained within specs. There is no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
[8113819]
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 | 2018433-2007-00240 |
| MDR Report Key | 950649 |
| Report Source | 01 |
| Date Received | 2007-11-16 |
| Date of Report | 2007-10-31 |
| Date Mfgr Received | 2009-03-27 |
| Device Manufacturer Date | 2007-04-20 |
| Date Added to Maude | 2009-04-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT MANUFACTURING, INC. |
| Manufacturer Street | 820 MISSION ST. |
| Manufacturer City | SOUTH PASADENA CA 91030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY IRON |
| Generic Name | FOR THE QUANTITATION OF IRON IN HUMAN SERUM |
| Product Code | CFM |
| Date Received | 2007-11-16 |
| Model Number | NA |
| Catalog Number | 7D68-30 |
| Lot Number | 52002HW00 |
| ID Number | NA |
| Device Expiration Date | 2008-03-29 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-16 |