MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2006-12-01 for ARCHITECT FSH CALIBRATOR 6C24-01 manufactured by Abbott Diagnostics International, Ltd..
[581307]
The customer states that they noticed a shift up in controls (biorad) and pt results when using the architect fsr assay with architect fsh calibrators lot number 33363q1. Pt results were reported out of the lab with qc out of range. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5
[7941951]
Following a customer complaint, abbott found an atypical stability profile of architect fsh calibrator lot 33363q100. The investigation to date has shown that both controls and pt results have shifted upwards together over time. There has been no adverse events associated with this issue to date. This is an intial 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 | 2623532-2006-00025 |
| MDR Report Key | 793635 |
| Report Source | 01,05,06 |
| Date Received | 2006-12-01 |
| Date of Report | 2006-08-31 |
| Date of Event | 2006-07-24 |
| Date Mfgr Received | 2006-08-31 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-12-14 |
| 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-D09Y6, 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 |
| Remedial Action | RC |
| 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 | 2006-12-01 |
| Model Number | NA |
| Catalog Number | 6C24-01 |
| Lot Number | 33363Q100 |
| ID Number | NA |
| Device Expiration Date | 2006-11-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 781252 |
| 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 | 2006-12-01 |