N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 6458526
- MDR report key
- 6458526
- Report number
- 3005094123-2017-00012
- Event key
- 0
- Event type
- 3
- Date received
- 2017-04-04
- 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 PROLACTIN | PROLACTIN | A.I.D.D LONGFORD | CFT | 07K76-35 | 67336UI00 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-04 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER OBSERVED FALSELY ELEVATED PROLACTIN RESULTS WHILE USING THE ARCHITECT PROLACTIN REAGENTS. THE FOLLOWING DATA WAS PROVIDED. INITIAL RESULT 45.2 NG/ML (951 MIU/L), REPEAT 52.28 NG/ML, 53.12 NG/ML RESULTS WERE LOWER AT ANOTHER FACILITY USING ANOTHER METHOD, APPROXIMATELY 19 NG/ML (400 MIU/L), HOWEVER THE METHOD USED AND THE SPECIFIC VALUE WERE NOT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
N
Patient 1
SUSPECT MEDICAL DEVICE 4 CATALOG # SHOULD HAVE BEEN 07K76-35 INSTEAD OF 7K76-25.
N
Patient 1
EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, LABELING REVIEW, DEVICE HISTORY REVIEW, AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. THE PRODUCT WAS NOT RETURNED. AN INTERNAL PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT AND ACCURACY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, THE ASSAY PERFORMED AS INTENDED, AND A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WERE NOT IDENTIFIED.