MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[23983843]
High test results. No consequences or impact to patient. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[23983844]
The customer observed a falsely elevated cyclosporine result while using the architect cyclosporine assay. The customer provided the following data: (b)(6) 2015: initial 513, retest 120 ng/ml the specimen was retested again and it was indicated the result was similar to the first retest result. Specific data was not provided. The result was not reported from the laboratory. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[27641124]
Further investigation of the customer issue included a review of the complaint text, in-house testing, a search for similar complaints, and a review of labeling. Return material was not available from the customer. An accuracy testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably. Tracking and trending did not identify an adverse trend for the lot in question. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency and no malfunction of the architect cyclosporine reagent, list 01l75, lot 43438m500, was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2015-00030 |
| MDR Report Key | 4957057 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2015-08-17 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-07-31 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| 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 | 2015-07-31 |
| Catalog Number | 01L75-25 |
| Lot Number | 43438M500 |
| Device Expiration Date | 2015-09-30 |
| 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 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |