N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 6477331
- MDR report key
- 6477331
- Report number
- 3005094123-2017-00014
- Event key
- 0
- Event type
- 3
- Date received
- 2017-04-10
- 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 | 07K76-25 | 70035UI00 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-10 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER OBSERVED FALSELY DEPRESSED PROLACTIN RESULTS ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 31.41, REPEAT 44.06 (28% SHIFT), SID (B)(6) INITIAL 54.27, REPEAT 76.28 (29% SHIFT), SID (B)(6) INITIAL 75.52, REPEAT 105.40 (28% SHIFT), SID (B)(6) INITIAL 16.10, REPEAT 21.87 (26% SHIFT) . INITIAL 17.62, REPEAT 23.96 (26% SHIFT), INITIAL 23.42, REPEAT 31.37 (25.4% SHIFT), INITIAL 16.05, REPEAT 21.72 (26% SHIFT), INITIAL 17.96, REPEAT 25.17 (29% SHIFT), INITIAL 14.27, REPEAT 19.15 (25.5% SHIFT), INITIAL 23.21, REPEAT 33.25 (30% SHIFT). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
N
Patient 1
FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. 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' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.