N
Patient 1
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.
MAUDE MDR 4957057
- MDR report key
- 4957057
- Report number
- 1415939-2015-00030
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-07-15
- Date received
- 2015-07-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NOEMI ROMERO-KONDOS, RN BSN
- Address
- 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
- Phone
- 224-224-2246
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT CYCLOSPORINE | CYCLOSPORINE | ABBOTT LABORATORIES | MKW | 01L75-25 | 43438M500 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-31 | 0 |
Event Narratives#
D
Patient 1
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.
N
Patient 1
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.