ALINITY I CMV IGG REAGENT KIT
Received Jun 28, 2023 · Event occurred May 10, 2023
Report 3008344661-2023-00121 · MDR key 17222054
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P42-23
Lot number
44231FN00
Product problems
- False Negative Result
- False Negative Result
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-23, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42--24/-33.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I CMV IGG RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT, ON 10MAY, WAS NEGATIVE; THE CMV IGM RESULT WAS POSITIVE. THE PATIENT WAS RECOLLECTED TWO WEEKS LATER, AND THE RESULT WAS NEGATIVE, THE CMV IGM RESULT WAS POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE 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 TESTING OF RETAINED REAGENT KITS OF THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 44231FN00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I CMV IGG, LOT NUMBER 44231FN00, WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I CMV IGG RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT, ON 10MAY, WAS NEGATIVE; THE CMV IGM RESULT WAS POSITIVE. THE PATIENT WAS RECOLLECTED TWO WEEKS LATER, AND THE RESULT WAS NEGATIVE, THE CMV IGM RESULT WAS POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.