N
Patient 1
(B)(6). (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 6098692
- MDR report key
- 6098692
- Report number
- 1415939-2016-00109
- Event key
- 0
- Event type
- 3
- Date received
- 2016-11-14
- 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 | 50164M500 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-14 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER OBSERVED FALSELY DECREASED CYCLOSPORINE RESULTS WHILE USING THE ARCHITECT CYCLOSPRORINE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA: PATIENT 1: INITIAL 18.6, RETESTS 84, 66, 243, 194, PATIENT 2: INITIAL 164.4, RETESTS 41, 45, 68, 21, 57, 29.2, PATIENT 3: INITIAL 107.4, RETESTS 217, 60, 343, 36, 70, 21.7, PATIENT 4: INITIAL 4.8, RETESTS 36, 185, 133, 27, 53, 94.8, PATIENT 5: INITIAL 6, RETESTS 99, 82, 25, 43, 230, 126.9, PATIENT 6: INITIAL 49.1, RETESTS 25, 122, 265, 122, 67, 29.6, PATIENT 7: INTIAL 4.5 RETESTS 14.5, 39, 308, PATIENT 8: INITIAL 68.2, RETESTS 101, 263, PATIENT 9: INTIIAL 25.9, RETESTS 85, 223, 323. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
N
Patient 1
FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE FROM THE CUSTOMER. 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 (B)(4), LOT 50164M500, WAS IDENTIFIED.
N
Patient 1
CORRECTION TO THE EVALUATION SUMMARY PREVIOUSLY DOCUMENTED. THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED. HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.