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 FSH CALIBRATOR 6C24-01 manufactured by Abbott Diagnostics International, Ltd..
[19646509]
This is the final report. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
[19679503]
This medwatch is being filed due to a customer complaint that was investigated. Abbott found an atypical stability profile for the lot of architect fsh calibrators list number 6c24-01 lot number 33363q100. Axsym fsh master calibrator list number 7a60-30 lot number 33266q100 and axsym fsh calibrator list number 9c06-01 were manufactured using the same base material as lot 33363q100; therefore, these lots are also impacted. The investigation to date has shown that both controls and pt results have shifted upwards over time together. A recall was issued for architect fsh calibrators list number 6c24-01 lot number 33363q100, axsym fsh master calibrator list number 7a60-30 lot number 33266q100 and axsym fsh calibrator list number 9c06-01. The issue was reported under 21 cfr 806 to the san francisco fda district office on 09/14/2006. Abbott has not rec'd any reports of adverse events due to this issue to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2623532-2006-00028 |
| MDR Report Key | 794755 |
| Report Source | 07 |
| Date Received | 2006-12-04 |
| Date of Event | 2006-09-07 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-12-18 |
| 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 RD |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0024-2007 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT FSH CALIBRATOR |
| Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERU |
| Product Code | CGJ |
| Date Received | 2006-12-04 |
| Model Number | NA |
| Catalog Number | 6C24-01 |
| Lot Number | 33363Q100 |
| ID Number | NA |
| Device Expiration Date | 2006-11-04 |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 782375 |
| Manufacturer | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. |
| Manufacturer Address | KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Baseline Brand Name | ARCHITECT FSH CALIBRATOR |
| Baseline Generic Name | CMIA FOR QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERUM AN |
| Baseline Model No | NA |
| Baseline Catalog No | 6C24-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-04 |