MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-12-04 for ARCHITECT FERRITIN 6C11-30 manufactured by Abbott Laboratories.
[580561]
This medwatch report is being filed due to a shift in pt and/or control results when changing to architect reagent and calibrator lots manufactured using the new internal reference standard. Also noted is the accuracy by correlation claim between architect ferritin and axsym ferritin as listed in the architect ferritin reagent package insert. A recall was issued and reported under 21 cfr 806 to the chicago fda district office on june 06, 2006. Abbott was not received any reports of adverse events associated with this issue.
Patient Sequence No: 1, Text Type: D, B5
[7986260]
This is a final report. An investigation is in-process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2006-00042 |
| MDR Report Key | 794319 |
| Report Source | 07 |
| Date Received | 2006-12-04 |
| Date of Event | 2006-06-06 |
| Date Added to Maude | 2006-12-15 |
| 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 | 0 |
| Manufacturer Contact | DR DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1204-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT FERRITIN |
| Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF FERRITIN |
| Product Code | JMG |
| Date Received | 2006-12-04 |
| Model Number | NA |
| Catalog Number | 6C11-30 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 781939 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | ARCHITECT FERRITIN |
| Baseline Generic Name | CMIA FOR THE QUANTITATIE DETERMINATION OF FERRITIN |
| Baseline Model No | NA |
| Baseline Catalog No | 6C11-30 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-04 |