CLIN CHEM LDH
Received Jan 10, 2017
Report 1628664-2017-00005 · MDR key 6239059
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Manufacturing IncCatalog number
02P56-21
Lot number
UNKNOWN
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
LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, ONLY A PARTIAL UDI IS KNOWN. 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 THE ARCHITECT ANALYZER GENERATED A FALSELY ELEVATED LDH RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL =400 / REPEAT = 200 (NORMAL RANGE 125-220U/L). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, TREND REPORTS, COMPLAINT SEARCHES, INSTRUMENT LOGS REVIEW, AND PRODUCT LABELING. THERE WAS NO PATIENT SAMPLE PROVIDED TO ASSIST IN THE INVESTIGATION. A REVIEW OF COMPLAINTS FOR THE PRODUCT DID NOT IDENTIFY ANY ISSUES OR TRENDS ASSOCIATED WITH THE CUSTOMER'S COMPLAINT. A REVIEW OF PRODUCT LABELING REVEALED ADEQUATE LABELING FOR THE HANDLING OF REAGENTS, SAMPLES, INTERPRETATION OF ASSAY RESULTS, AND TROUBLESHOOTING OF THE INSTRUMENT FOR THIS COMPLAINT ISSUE. THE CUSTOMER'S INSTRUMENT HISTORY LOG FILE WAS REVIEWED FROM 21JUN2016 THROUGH 21DEC2016 AND FOUND 176 INSTANCES OF ERROR CODE 3375 (ASPIRATION ERROR), POTENTIALLY INDICATING A PRESENCE OF FOAM, BUBBLES, OR FIBRIN IN SAMPLES. THERE WERE ALSO SOME INSTANCES OF ERROR CODE 0550 (INSTRUMENT HARD STOPS) IN THIS TIMEFRAME INDICATING THE CUVETTE WASHING WAS NOT COMPLETED, AND THAT THE CUVETTE WASH (6052) PROCEDURE SHOULD BE PERFORMED. THE CUSTOMER'S MAINTENANCE FILE WAS REVIEWED FOR THIS TIMEFRAME AND THE CUVETTE WASH (6052) PROCEDURE WAS NOT PERFORMED DURING THOSE 6 MONTHS. ABBOTT RECOMMENDS THIS PROCEDURE BE COMPLETED AFTER EVERY 0550 ERROR CODE IN ORDER TO KEEP THE CUVETTES CLEAN. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS INVESTIGATION NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.
Additional Manufacturer Narrative
THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE THE DEVICE WAS NOT PERFORMING AS INTENDED.