MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-07 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[10781323]
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 < 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
[19731166]
The customer experienced falsely elevated cyclosporine results for one patient ((b)(6)) on the architect i1000sr analyzer. The customer provided data ranging from 52. 5 to 1364 ng/ml. The customer is specifically questioning the results from (b)(6) (628. 6, 1364 and 294. 1 ng/ml). No adverse impact to management was reported. The complete data provided is architect compared to mass specdate arch mass spec(b)(6) 59. 8 66. 1(b)(6) 52. 5 32(b)(6) 66 52(b)(6) 145. 6 95(b)(6) 547. 4 419. 3(b)(6) 749. 1 572. 8(b)(6) 195. 1 128. 5(b)(6) 195. 7 95(b)(6) 141. 2 128(b)(6) 175. 2 97(b)(6) 406 279(b)(6) 344 218. 7(b)(6) 292. 1 189. 6(b)(6) 190 112. 3(b)(6) 628. 6 537. 7(b)(6) 1364 810(b)(6) 294. 1 158. 8(b)(6) 162. 7 98. 6(b)(6) 163. 5 119. 8(b)(6) 130. 4 117
Patient Sequence No: 1, Text Type: D, B5
[19835485]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28310948]
On 9/18/13 product quality determined the issue is not related to the previous investigation. Upon further review it was decided that the customer issue of discrepant architect cyclosporine assay results reported in this complaint is not associated with the deficiency documented as the most probable cause of a change in resin to the architect reaction vessel (rv) sourced from a new vendor and has been unassigned to these actions. An investigation is pending and a follow up will be submitted when the investigation is complete. An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[32665843]
Further investigation of the customer issue included a review of historical and complaint data, a review of labeling, and accuracy testing. Review of the data did not identify any product issue or adverse trend. Labeling was reviewed and found to be adequate. All accuracy test results met acceptance criteria. Based on the results of this investigation, no malfunction or deficiency was identified and the architect cyclosporine reagents are performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00197 |
| MDR Report Key | 3095966 |
| Report Source | 05 |
| Date Received | 2013-05-07 |
| Date of Report | 2013-03-25 |
| Date of Event | 2013-02-24 |
| Date Mfgr Received | 2013-10-16 |
| Device Manufacturer Date | 2013-07-20 |
| Date Added to Maude | 2013-05-07 |
| 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 | 2013-05-07 |
| Catalog Number | 01L75-25 |
| Lot Number | 18265M500 |
| Operator | OTHER |
| 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 | 2013-05-07 |