MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,foreign,health professi report with the FDA on 2015-06-30 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[20037271]
The customer states that one patient sample generated architect cyclosporine assay results of 231. 8 and 130. 7 ug/l. Controls were not run on this day because the customer did not have any at hand, but they were within specifications on the day the assay was calibrated. The result of 231. 8 ug/l was reported from the lab as a consequence of the configuration of the customer's laboratory interface and questioned by the patient's physician as not fitting the patient's clinical condition. The sample was sent to two different labs for testing (methods unknown) and results of 190. 2 and 58. 0 ug/l were returned. The customer then retested the sample at their facility and generated a result of 132. 3 ug/l. Previously, this patient had generated results of 99, 100 and 110 ug/l. There has been no impact to patient care reported.
Patient Sequence No: 1, Text Type: D, B5
[20287454]
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
[26768031]
No returns were made available from the customer site for this evaluation. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. Accuracy testing was performed using in-house retained reagents of lot 43438m500. Replicates of a patient sample matrix based panel were tested on one architect i-system. All results fell within specifications, indicating acceptable performance of this assay lot. The architect cyclosporine assay package insert contains information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. The issue involved one discreet patient sample and multiple retests of the sample produced inconsistent results indicating a possible sample integrity issue. Additionally, the customer did not run controls for the assay on the day the patient sample was tested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2015-00020 |
| MDR Report Key | 4879867 |
| Report Source | 01,05,FOREIGN,HEALTH PROFESSI |
| Date Received | 2015-06-30 |
| Date of Report | 2015-06-10 |
| Date Mfgr Received | 2015-08-06 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-07-16 |
| 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 | 2015-06-30 |
| Catalog Number | 01L75-25 |
| Lot Number | 43438M500 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-30 |