MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-04-08 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[4324575]
The customer observed a falsely elevated cyclosporine result for one patient on the architect i1000sr analyzer. The following data was provided: initial 1300 ug/l (suspect falsely elevated, questioned by the doctor). 1:4 dilution and obtained <800 ug/l with a cnrl flag, repeated the sample neat 1000 ug/l. 1:4 dilution 50 ug/l (the dilution factor was not keyed in however), there was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[11822670]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4). An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[11986403]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and accuracy testing. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The product was not available for return. Accuracy testing of the reagent lot with two levels of an internal panel (each level contains a known concentration of the cyclosporine analyte) met all specifications. Complaint information reasonably suggests the assay is performing as intended, and no malfunction of the device occurred. Based on the available information, no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2014-00087 |
| MDR Report Key | 3734577 |
| Report Source | 01,05 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-03-21 |
| Date Mfgr Received | 2014-08-15 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-04-09 |
| 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 |
| Generic Name | CYCLOSPORINE |
| Product Code | MKW |
| Date Received | 2014-04-08 |
| Catalog Number | 01L75-25 |
| Lot Number | 33387M500 |
| Device Expiration Date | 2014-10-16 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-04-08 |