MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-12-01 for AXSYM FSH CALIBRATOR 9C06-01 manufactured by Abbott Diagnostics International, Ltd..
[21323498]
Following a customer complaint, abbott found an atypical stability profile of architect fsh calibrator lot 33363q100. Axsym fsh calibrator lot 33362q100 was mfg using the same base material as lot 33363q100; therefore, this lot is also impacted. 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
[21392464]
The customer states that qc (biorad) has been running high out of range for the axsym fsh assay. No suspect results were generated or reported out of the lab. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2623532-2006-00024 |
| MDR Report Key | 793663 |
| Report Source | 05,06 |
| Date Received | 2006-12-01 |
| Date of Report | 2006-10-13 |
| Date of Event | 2006-10-05 |
| Date Mfgr Received | 2006-10-13 |
| Device Manufacturer Date | 2005-10-01 |
| 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 | AXSYM FSH CALIBRATOR |
| Generic Name | MEIA FOR THE QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERU |
| Product Code | CGJ |
| Date Received | 2006-12-01 |
| Model Number | NA |
| Catalog Number | 9C06-01 |
| Lot Number | 33362Q100 |
| 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 | 781280 |
| Manufacturer | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Baseline Brand Name | AXSYM FSH CALIBRATOR |
| Baseline Generic Name | MSIA FOR THE QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERU |
| Baseline Model No | NA |
| Baseline Catalog No | 9C06-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-01 |