MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-12-18 for IMX SIROLIMUS REAGENT 5C91-21 manufactured by Abbott Laboratories.
[541088]
New studies have determined that imx sirolimus values may shift after storage at 23-8 degrees c or with freeze thaw of speciments. It has beendetermined that the observed changes are generally not clinically significant. A recall was issued and reproted under 21 cfr 806 to the fda on 12/18/06. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[7986411]
The properties of sirolimus in stored whole blood observed in development were not fully understood at the time; therefore, information regarding the analyte properties that were identified recently were not included in product labling for specimen collection and storage. The sirolimus package insert is being updated to provide new info regarding sample storage and handling. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2006-00075 |
| MDR Report Key | 798228 |
| Report Source | 07 |
| Date Received | 2006-12-18 |
| Date of Report | 2006-12-14 |
| Date of Event | 2006-08-11 |
| Date Mfgr Received | 2006-12-14 |
| Date Added to Maude | 2006-12-27 |
| 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, AP8C-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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 14159390-12/18/06-005-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX SIROLIMUS REAGENT |
| Generic Name | MEIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS |
| Product Code | JJI |
| Date Received | 2006-12-18 |
| Model Number | NA |
| Catalog Number | 5C91-21 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 785761 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | O,X SORP;O,IS REAGEMT |
| Baseline Generic Name | MEIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS |
| Baseline Model No | NA |
| Baseline Catalog No | 5C91-21 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-18 |