MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-12-18 for IMX SIROLIMUS REAGENT 5C91-21 manufactured by Abbott Laboratories.
[14865479]
The customer states that they have been performing correlation studies with the imx sirolimus assay versus hplc and results have been acceptable. Recently, however, imx sirolimus results are not consistent with previous results and the values are now lower than the hplc values. The customer has been attaching imx sirolimus results as a footnote to the primary reported results from hplc. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[15141319]
The product issue was an observed shift by a customer in imx sirolimus patient results between freshly drawn and stored (2-8 degrees c) whole blood samples after 24 hours. The investigation identified the cause as 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 labeling for specimen collection and storage. The studies determined that sample values may shift after storage at 2-8 degrees c or with freeze/thaw of specimens; however, the observed difference is generally not clinically significant. The investigation concluded that product performance has not changed since development of the assay, and that there is no impact on product functionality or product performance as a result of this issue. The reagent assay system is performing as intended. The sirolimus package insert is being updated to provide new information regarding sample storage and handling. Abbott has not received any reports of adverse events related to the affected lots of imx sirolimus reagents. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2006-00072 |
| MDR Report Key | 798799 |
| Report Source | 05,06 |
| Date Received | 2006-12-18 |
| Date of Report | 2006-12-14 |
| Date of Event | 2006-11-15 |
| Date Mfgr Received | 2006-12-14 |
| Date Added to Maude | 2006-12-28 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-12/18/06-005-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX SIROLIMUS REAGENT |
| Generic Name | MEIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS |
| Product Code | NRP |
| Date Received | 2006-12-18 |
| Model Number | NA |
| Catalog Number | 5C91-21 |
| Lot Number | 052511 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 786327 |
| 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 |