MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2008-09-17 for CLINICAL CHEMISTRY IRON 7D68-30 manufactured by Abbott Manufacturing, Inc..
[8647375]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[17066652]
The account stated that the results from the architect iron assay are non-reproducible. For patient #2, the initial result= 6 ug/dl, the sample was then tested in duplicate and both results were 15 ug/dl. The account states the initial result which is too low is the incorrect result. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[17229848]
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
[19715765]
(b)(4). The customer was complaining of iron reproducibility issues. Maintenance was up to date. Customer using clinical chemistry iron, ln 7d68-30, exp 10/30/2008 and iron/mg calibrator, ln 1e69-03, exp 6/9/2008. It was later identified the customer was using expired calibrators when the suspect results were generated. Review the clinical chemistry iron/ magnesium calibrator package insert commodity #(b)(4) was performed. Page 1, "warnings and precautions" section states; "do not use components beyond the expiration date". Review of the abbott metric reports indicated no similar complaints were found. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2008-00185 |
| MDR Report Key | 1171505 |
| Report Source | 00,01 |
| Date Received | 2008-09-17 |
| Date of Report | 2008-09-03 |
| Date of Event | 2008-09-01 |
| Date Mfgr Received | 2010-05-24 |
| Device Manufacturer Date | 2007-12-09 |
| Date Added to Maude | 2010-05-24 |
| 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 | 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 91030350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91030 3500 |
| 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 | 2008-09-17 |
| Model Number | NA |
| Catalog Number | 7D68-30 |
| Lot Number | 60030HW00 |
| ID Number | NA |
| Device Expiration Date | 2007-06-09 |
| 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 91030350 US 91030 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-17 |