CLINICAL CHEMISTRY LACTATE DEHYDROGENASE
Received Jan 30, 2019 · Event occurred Jan 10, 2019
Report 1628664-2019-00074 · MDR key 8290951
Device
Generic name
Lactate Dehydrogenase,
Manufacturer
Abbott Manufacturing IncCatalog number
02P56-21
Lot number
73199UN18
Product problems
- High Test Results
- High Test Results
Patient
49 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR PATIENT IDENTIFIER = (B)(6).
Description of Event or Problem
THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT LDH RESULTS FOR A PATIENT. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 997.5 U/L AND RETEST RESULTS OF 168.5 U/L AND 161 U/L. THE SAME SAMPLE WAS RAN ON TWO OTHER ANALYZERS AND GENERATED RESULTS OF 167 AND 163 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
REVIEW OF THE COMPLAINT ACTIVITY FOR THE LACTATE DEHYDROGENASE ASSAY DID NOT IDENTIFY ANY ADVERSE OR NON-STATISTICAL TRENDS. A SEARCH FROM SIMILAR COMPLAINTS ASSOCIATED WITH LOT 73199UN18 ONLY IDENTIFIED ONE OTHER COMPLAINT. THE CUSTOMERS INSTRUMENT LOGS WERE REVIEWED. THIS REVIEW FOUND LEVEL 2 AND 3 QUALITY CONTROLS WERE RAN AND WITHIN THE EXPECTED RANGES. MANUFACTURING DOCUMENTATION FOR THE ASSAY DID NOT IDENTIFY ANY ISSUES. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE ASSAY WAS IDENTIFIED.