ARCHITECT CMV IGG REAGENT KIT
Received Feb 22, 2023 · Event occurred Feb 16, 2023
Report 3008344661-2023-00042 · MDR key 16420712
Device
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
B5 - DESCRIBE EVENT OR PROBLEM: ADDITIONAL SPECIFIC PATIENT RESULT VALUES WERE OBTAINED ON 24FEB2023 AND ADDED TO THE DESCRIPTION OF THE EVENT IN SECTION B5. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 6.0 AU/ML IS NONREACTIVE AND > OR = 6.0 AU/ML IS REACTIVE): SID (B)(6): INITIAL CMV IGG RESULT ON ARCHITECT: 85.6 AU/ML (REACTIVE). RETEST ON ANOTHER ANALYZER (NON-ABBOTT PLATFORM): NEGATIVE. RETEST ON ARCHITECT: 0.8 AU/ML (NONREACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ARCHTIECT CMV IGG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. COMPLAINT ACTIVITY WAS REVIEWED AND THE SEARCH BY LOT 44845FN00 INDICATES NORMAL COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. A RETAINED REAGENT KIT OF THE COMPLAINT LOT 44845FN00 WAS TESTED IN A SPECIFICITY SETUP. ALL SPECIFICATIONS WERE MET, AND NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SPECIFICITY PERFORMANCE IS NOT IMPACTED. A REVIEW OF DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER 44845FN00 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ARCHITECT CMV IGG REAGENT LOT 44845FN00.
Additional Manufacturer Narrative
ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 POSITIVE ARCHITECT CMV IGG RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6): INITIAL CMV IGG RESULT ON ARCHITECT: POSITIVE. RETEST ON ANOTHER ANALYZER (NON-ABBOTT PLATFORM): NEGATIVE. RETEST ON ARCHITECT: NEGATIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.