ARCHITECT B12
Received Nov 20, 2019
Report 3005094123-2019-00326 · MDR key 9348329
Device
Generic name
Vitamin B12
Manufacturer
Abbott Ireland Diagnostics Division LongfordCatalog number
07K61-25
Lot number
04209UI00
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW OF COMPLAINTS DETERMINED THERE IS NORMAL COMPLAINT ACTIVITY FOR THE ARCHITECT B12 REAGENT LOT 04209UI00. TRACKING AND TRENDING REPORT WAS REVIEWED AND DETERMINED THERE IS NO RELATED TREND FOR THE ARCHITECT B12 REAGENT. WORLDWIDE FIELD DATA WAS REVIEWED TO EVALUATE THE HISTORICAL PERFORMANCE OF THE ARCHITECT B12 REAGENT LOTS IN THE FIELD; THE PATIENT MEDIAN RESULT FOR LOT 04209UI00 IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD, CONFIRMING THERE IS NO SYSTEMIC ISSUE FOR THE LOT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT B12 REAGENT.
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 STATED THAT FALSELY ELEVATED ARCHITECT B12 RESULTS OF 1,840 AND 1,445 PG/ML WERE GENERATED FOR TWO PATIENT SAMPLES THAT RETESTED AT 238.20 AND 244.60 PG/ML RESPECTIVELY USING THE ROCHE METHOD. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.