MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-11-12 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[3028103]
The account stated patient id: (b)(6) generated a falsely elevated architect cyclosporine of 208. 5 ng/ml on a patient who repeated lower at 91. 10 ng/ml. No specific patient information was provided. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[10309423]
(b)(6). (b)(4). A product deficiency has been identified and an investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[19319751]
Investigations were conducted to find the probable cause of the architect cyclosporine assay discrepant patient results. It was concluded that the most probable cause was a reaction vessel (rv) resin change sourced from a new vendor. When the customer mixed reaction vessels from both resin lots for assay calibration and/or assay test runs, an increase in discrepant results was seen along with calibration failures and controls shifting and/or reading out of specifications. It was found that there is greater adherence of the cyclosporine/microparticle-cyclosporine complex to the rv wall for rvs made using the resin from the new vendor versus the resin rvs from the former vendor. The investigation also found that the resin rv lot to lot variability of the new vendor is not causing assay performance issues and that the resin change did not cause sample concentration shifts in customer data. Customers had been informed by product correction letter (b)(4) to only use rv lots manufactured with the same resin for the architect cyclosporine assay. If these instructions are followed, assay precision is restored to within package insert claims. Per current product availability, only the new vendor resin is now being manufactured and used exclusively for reaction vessel production. Since using the reaction vessels manufactured with the new resin formulation, the calibration curve is slightly flatter, which results in higher %cvs than previously observed with the assay, but still within precision claim of less than 15 %. The architect cyclosporine assay will be included in future testing of any resin changes. Improvement efforts are ongoing and planned to be finalized fourth quarter 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2012-02075 |
| MDR Report Key | 2828142 |
| Report Source | 01,05 |
| Date Received | 2012-11-12 |
| Date of Report | 2012-10-18 |
| Date of Event | 2012-10-15 |
| Date Mfgr Received | 2013-05-23 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2012-11-16 |
| 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 ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT CYCLOSPORINE |
| Product Code | MKW |
| Date Received | 2012-11-12 |
| Catalog Number | 01L75-25 |
| Lot Number | 14846M500 |
| Device Expiration Date | 2013-03-14 |
| 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 | 2012-11-12 |