MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-08-20 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[3831545]
The customer reports a falsely decreased architect cyclosporine assay result for one patient sample tested on the architect 12000sr analyzer. The customer provided the following information: (b)(6) 2013: a result of 1250 ng/ml was generated one hour after drug administration; (b)(6) 2013: a result of 612 ng/ml was generated one hour after drug administration; (b)(6) 2013: a result of 146 ng/ml was generated one hour after drug administration; and, (b)(6) 2013: a result of greater than 1500 ng/ml was generated one hour after drug administration. The customer claims that the (b)(6) 2013 result of 146 ng/ml is falsely decreased. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[11069880]
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
[32665933]
Accuracy testing was performed to evaluate the performance of reagent lot 22639m500. Testing was performed using retained kits of the reagent lot and two internal cyclosporine panels, which consist of edta human whole blood containing cyclosporine human patient samples. All replicates of the cyclosporine panels were within specification, which demonstrates that the assay can accurately detect a known concentration of cyclosporine. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect cyclosporine package insert contains information to address the current customer concern. Based on the results of the current evaluation, the architect cyclosporine reagent kit, lot 22639m500, is performing as intended. A product malfunction was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00321 |
| MDR Report Key | 3297984 |
| Report Source | 01,05 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-08-09 |
| Date of Event | 2013-07-19 |
| Date Mfgr Received | 2013-10-23 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-11-14 |
| 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 | 2013-08-20 |
| Catalog Number | 01L75-25 |
| Lot Number | 22639M500 |
| Device Expiration Date | 2014-01-02 |
| Operator | OTHER |
| Device Availability | N |
| 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 | 2013-08-20 |