ARCHITECT CMV IGG REAGENT KIT
Received Jul 25, 2023 · Event occurred Jul 12, 2023
Report 3008344661-2023-00133 · MDR key 17387744
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
06C15-25
Lot number
49574FN00
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT CMV IGG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 7.7 / 0.2 AU/ML (> 6 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ARCHITECT CMV IGG REAGENT LOT 49574FN00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. A RETAINED KIT OF REAGENT LOT 49574FN00 WAS TESTED FOR SPECIFICITY AND THE DATA SHOWS THAT THE PERFORMANCE OF LOT 49574FN00 IS NOT ADVERSELY AFFECTED. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CMV IGG (LOT# 49574FN00).
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT CMV IGG RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 7.7 / 0.2 AU/ML (> 6 IS REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.