MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-05-27 for IMX SIROLIMUS 5C91-21 manufactured by Abbott Laboratories.
[1550791]
Abbott imx sirolimus reagent lot 802873106 is exhibiting higher than normal complaint activities related to three calibration errors. When the calibration errors are generated, there is no impact to patient results because no results can be reported, therefore, a delay in patient results can occur. When a valid calibration curve is obtained, a calibration curve shape is achieved that will give accurate results. The control values generated from a valid calibration curve assure accurate results are derived. A product recall has been issued and reported under 21cfr806 for the abbott imx sirolimus reagent lot 802873106 to the fda (b)(4) on (b)(4) 2010. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[8652714]
(b)(4). The imx sirolimus calibration errors generated with reagent lot 802873106 are caused by a calibration curve ratio outside the imx sirolimus assay file limits for imx sirolimus calibrator b/calibrator a and calibrator f/calibrator a. A product recall was issued and a letter was sent to abbott customers with instructions to discontinue use and destroy the suspect imx sirolimus reagent and switch to a replacement lot of reagent.
Patient Sequence No: 1, Text Type: N, H10
[8908475]
(b)(4), suspect medical device, expiration date: the correct expiration date of imx sirolimus reagent lot 802873106 is 5/13/10, not 7/23/10 as was submitted in the initial medwatch submission. Suspect medical device, expiration date was corrected in this submission. The imx sirolimus calibration errors generated with reagent lot 802873106 were caused by a calibration curve ratio outside the imx sirolimus assay file limits for the imx sirolimus calibrator b/calibrator a and calibrator f/calibrator a. A product recall was issued and a letter was sent to abbott customers with instructions to discontinue use and destroy the suspect imx sirolimus reagent and switch to a replacement lot of reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00318 |
| MDR Report Key | 1700057 |
| Report Source | 07 |
| Date Received | 2010-05-27 |
| Date of Report | 2010-04-30 |
| Date of Event | 2010-04-30 |
| Date Mfgr Received | 2010-11-24 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2011-04-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-5/3/10-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX SIROLIMUS |
| Generic Name | FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS IN HUMAN WHOLE BLOOD |
| Product Code | NRP |
| Date Received | 2010-05-27 |
| Catalog Number | 5C91-21 |
| Lot Number | 802873106 |
| Device Expiration Date | 2010-05-13 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-27 |