LACTATE DEHYDROGENASE
Received Jul 19, 2019 · Event occurred Jun 23, 2019
Report 1628664-2019-00514 · MDR key 8808523
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Manufacturing IncCatalog number
02P56-21
Lot number
55176UN18
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PATIENT IDENTIFIER = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. HISTORICAL QUALITY METRICS WERE REVIEWED, AND NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE INSTRUMENT HISTORY LOG SHOWS THAT FROM (B)(6) 2019 THROUGH (B)(6) 2019 THERE ARE 35 OCCURRENCES OF ERROR CODE 0550, CUVETTE WASHING NOT COMPLETED ERROR. NO ERRORS OCCURRED AT THE TIME THE ABNORMAL LOW RESULTS WERE TESTED. A SYSTEM FACTOR THAT MAY IMPACT RESULTS IS THE FAILURE TO ALLOW CUVETTE WASHING TO COMPLETE, RESULTING IN DIRTY CUVETTES AND CUVETTE DRYER TIPS. INCOMPLETE CUVETTE WASHING WILL GENERATE ERROR CODE 0550. THE ISSUES THAT TRIGGERED THESE ERRORS CAN CONTRIBUTE TO, OR CAUSE, THE DISCREPANT RESULTS ISSUE OBSERVED. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISION ON THE ARCHITECT C16000 SYSTEM. SID (B)(6): LDH RESULT OF 267 U/L RETESTED AT 132. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.