MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-08-29 for ARCHITECT CYCLOSPORINE 01L75-25 manufactured by Abbott Laboratories.
[118889709]
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
[118889710]
The customer observed falsely depressed results while using architect cyclosporine reagents. The customer stated the architect method values were lower in their lab than in another support lab using the same method, however specific results for the specimen were not provided. The following data was provided for a specimen with a known value (106 ng/ml). Initial 112. 3 ng/ml, repeat 63. 5, 94. 4 ng/ml. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2018-00126 |
| MDR Report Key | 7827876 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-29 |
| Date of Report | 2018-10-26 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2017-12-01 |
| Date Added to Maude | 2018-08-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-08-29 |
| Catalog Number | 01L75-25 |
| Lot Number | 80012M800 |
| Device Expiration Date | 2018-09-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-08-29 |