MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-03-06 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[15099207]
The customer stated that one patient sample (specimen? ) generated higher than expected results of 120 and 140 ng/ml for the architect cyclosporine assay. The patient sample had previously (2 days earlier) generated an expected result of 71 ng/ml. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[15417105]
(b)(4). Product evaluation is in process and the results will be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[22339097]
Product evaluation was completed in order to investigate this issue. Review of ticket trending and lot search data did not identify atypical complaint activity related to the complaint issue. Accuracy testing was completed using retained kits of reagent lot 16054m500. Acceptance criteria were met, which indicates acceptable product performance. A deficiency was not identified as panel testing shows that the likely cause lot performs per specification. Based on the evaluation results, no malfunction of the lot in question was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00093 |
| MDR Report Key | 2991415 |
| Report Source | 01 |
| Date Received | 2013-03-06 |
| Date of Report | 2013-02-14 |
| Date of Event | 2013-02-14 |
| Date Mfgr Received | 2013-05-07 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-03-07 |
| 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 | 2013-03-06 |
| Catalog Number | 01L75-25 |
| Lot Number | 16054M500 |
| Device Expiration Date | 2013-05-09 |
| 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 | 2013-03-06 |