N
Patient 1
(B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
MAUDE MDR 5736198
- MDR report key
- 5736198
- Report number
- 1415939-2016-00068
- Event key
- 0
- Event type
- 3
- Date received
- 2016-06-20
- 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 INSULIN | INSULIN | ABBOTT LABORATORIES | CFP | 08K41-27 | 60151LP76 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-06-20 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT INSULIN ASSAY RESULTS FOR 3 PATIENTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA. THE RETEST RESULTS WERE GENERATED AT ANOTHER LABORATORY, TEST METHOD/ PLATFORM IS UNKNOWN): SAMPLE 1: INITIAL 27 RETEST 14; SAMPLE 2: INITIAL 30 RETEST 17; SAMPLE 3 INITIAL 38 RETEST 9. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.
N
Patient 1
ON (B)(6) 2016 THE SUSPECT MEDICAL DEVICE LOT NUMBER WAS UPDATED. THIS IS DOCUMENTED. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, A BATCH RECORD REVIEW 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. NO ISSUES WERE IDENTIFIED WHICH WOULD INDICATE A PRODUCT DEFICIENCY FROM THE BATCH RECORD REVIEW. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT INSULIN REAGENT, LIST (B)(4), LOT 60121LP76, WAS IDENTIFIED.
N
Patient 1
CORRECTION TO THE EVALUATION SUMMARY PREVIOUSLY DOCUMENTED. THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DOCUMENTATION OF NO MALFUNCTION IS INACCURATE. HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.