MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-07-15 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[3683204]
The customer stated an architect i2000sr analyzer generated a false elevated cyclosporine result for one patient sample. The analyzer generated a cyclosporine result of 350 ng/ml for a patient who had generated a previous result of 140 ng/ml. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[10903248]
(b)(4). A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[26493372]
Further investigation of the customer issue included a review of the complaint text, accuracy testing, a search for similar complaints, and a review of labeling. Accuracy testing was completed using retained kits of cyclosporine reagent lot 22639m500 and acceptance criteria was met. Tracking and trending identified no adverse trends related to the customer's issue. Labeling was reviewed and found to be adequate. Based on the investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00293 |
| MDR Report Key | 3226973 |
| Report Source | 01 |
| Date Received | 2013-07-15 |
| Date of Report | 2013-07-02 |
| Date Mfgr Received | 2013-09-30 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-07-24 |
| 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 | 2013-07-15 |
| Catalog Number | 01L75-25 |
| Lot Number | 22639M500 |
| Device Expiration Date | 2014-01-02 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-07-15 |