CONTROL SET FOR THE BD PROBETEC (CT/GC) QX AMPLIFIED DNA ASSAYS
Received Feb 10, 2021 · Event occurred Dec 14, 2020
Report 1119779-2021-00283 · MDR key 11308646
Device
Generic name
Dna Reagents, Neisseria
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
441125Catalog number
441125
Lot number
0247078
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING SEVERAL INVALID CT/GC POSITIVE CONTROL RESULTS. QUALITY INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS AND FUNCTIONAL ANALYSIS OF RETENTION MATERIALS FROM THE CUSTOMERS REPORTED REAGENT BATCH AS WELL AS COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS OF RETENTION MATERIALS PASSED WITH 100% POSITIVITY FOR CT AND GC. QUALITY WAS UNABLE TO DUPLICATE THE CUSTOMERS REPORTED FAILURE MODE. THERE ARE NO CURRENT COMPLAINT TRENDS AGAINST INVALID CT/GC POSITIVE CONTROL RESULTS ON THE VIPER XTR SYSTEM. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH INVALID CT/GC POSITIVE CONTROL RESULTS.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS 4 FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.