ALINITY I CMV IGG REAGENT KIT
Received May 4, 2023 · Event occurred Dec 19, 2022
Report 3008344661-2023-00089 · MDR key 16872071
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P42-22
Lot number
45608FN00
Product problems
- False Positive Result
- False Positive Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I CMV IGG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE SENSITIVITY TESTING. TRENDING REVIEW DID NOT IDENTIFY ANY RELATED TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS WITH LOT 45608FN00 AND THE COMPLAINT ISSUE. IN-HOUSE SPECIFICITY TESTING USING A RETAINED REAGENT KIT OF LOT 45608FN00 WAS COMPLETED. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CMV IGG REAGENT FOR LOT 45608FN00 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SID (B)(6) INITIAL RESULT = 0.2 AU/ML, CMV IGM RESULT = 0.06. (B)(6) 2023 SID (B)(6) INITIAL RESULT = 68.9 AU/ML, CMV IGM RESULT = 0.07. (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.1 AU/ML, CMV IGM RESULT = 0.06 . THE CUSTOMER IS QUESTIONING THE INITIAL RESULT FROM SID (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT FOR A PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6)2022 SID (B)(6) INITIAL RESULT = 0.2 AU/ML, CMV IGM RESULT = 0.06 . (B)(6) 2023 SID (B)(6) INITIAL RESULT = 68.9 AU/ML, CMV IGM RESULT = 0.07. (B)(6) 2023 SID (B)(6) INITIAL RESULT = 0.1 AU/ML, CMV IGM RESULT = 0.06 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4).