| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT INSULIN | INSULIN | ABBOTT LABORATORIES | CFP | 08K41-26 | 33020LP52 | Y | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-03-28 | 0 |
Patient 1
THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED INSULIN RESULTS ON ONE PATIENT SAMPLE. SID (B)(6) INITIAL INSULIN ON (B)(6) 2014 = >300UU/ML / 1:2 DILUTION RESULT = >600UU/ML. THE PATIENT SAMPLE WAS SENT OUT AND THE LUMIPULSE RESULT = 2.0UU/ML. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient 1
(B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Patient 1
FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW FOR SIMILAR COMPLAINTS, ACCURACY TESTING, AND A REVIEW OF LABELING. THE CUSTOMER REPORTED FALSELY ELEVATED INSULIN RESULTS. A REVIEW OF COMPLAINTS DID NOT IDENTIFY ANY ISSUES FOR FALSELY ELEVATED INSULIN RESULTS FOR LOT 33020LP52. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 33020LP52. A DEFICIENCY WAS NOT IDENTIFIED AS THE TESTING SHOWED THAT LOT 33020LP52 PERFORMED PER SPECIFICATION. THE TESTING SHOWED THAT ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES THE PRODUCT IS PERFORMING ACCEPTABLY. NO MALFUNCTION WAS IDENTIFIED. A REVIEW OF LABELING DETERMINED THAT THE ASSAY VALUES WERE OBTAINED WITH DIFFERENT METHODS, WHICH CANNOT BE USED INTERCHANGEABLY, DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. NO ADDITIONAL ISSUES WERE IDENTIFIED; NO FURTHER ACTION IS REQUIRED AT THIS TIME. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND THE ARCHITECT INSULIN REAGENT IS PERFORMING AS INTENDED.