LACTATE DEHYDROGENASE
Received Jul 22, 2019
Report 1628664-2019-00516 · MDR key 8814559
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 Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INSTRUMENT HISTORY LOG SHOWS THAT FROM 01APR2019 THROUGH 17JUN2019 THERE ARE 208 OCCURRENCES OF ERROR CODE 0550 CUVETTE WASHING NOT COMPLETED ERROR, HARDWARE FAILURE OR USER PRESSED STOP, AND 543 OCCURRENCES OF ERROR CODE 3375 UNABLE TO PROCESS TEST, ASPIRATION ERROR OCCURRED. THE MAINTENANCE LOG SHOWS PERIODIC MAINTENANCE WAS PERFORMED AS REQUIRED; HOWEVER, THE AS-NEEDED MAINTENANCE PROCEDURE 6052 WASH CUVETTES WAS NOT PERFORMED FOLLOWING ANY OF THE OCCURRENCES OF ERROR CODE 0550 AS INSTRUCTED IN THE ARCHITECT OPERATIONS MANUAL. THE QUALITY CONTROL LOG REVIEW OF OCT 2018 THROUGH JUNE 2019 SHOWS QUALITY CONTROL IN RANGE. THE TREND REVIEW BY THE PRODUCT LIST NUMBER FOUND NO ADVERSE TRENDS RELATED TO THIS ISSUE. A DEVICE HISTORY REVIEW SHOWED NO ISSUES THAT WERE ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. NO CUSTOMER RETURN WAS AVAILABLE FOR EVALUATION. NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Additional Manufacturer Narrative
THE COMPLETE ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IS IN PROCESS.
Description of Event or Problem
THE ACCOUNT GENERATED FALSELY ELEVATED ARCHITECT LDH OF 504 U/L THAT REPEATED 154 AND 156 U/L WITH SID (B)(6). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.