LACTATE DEHYDROGENASE
Received Jul 15, 2019
Report 1628664-2019-00499 · MDR key 8789885
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
NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. A REVIEW OF TICKET TRENDING AND PRODUCT LOT NUMBER (55176UN18) SEARCH DID IDENTIFY TWO ADDITIONAL COMPLAINTS THAT WERE SIMILAR FOR FALSELY ELEVATED LDH PATIENT RESULTS. IN BOTH CASES, ONLY ONE SAMPLE WAS INVOLVED AND BOTH SAMPLES WERE REPEATED AND FOUND TO BE IN THE NORMAL RANGE. THE TREND REVIEW BY THE PRODUCT LIST NUMBER FOUND NO ADVERSE OR NON-STATISTICAL TRENDS RELATED TO THIS ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. NO PRODUCT DEFICIENCY WAS IDENTIFIED. SECTION A. PATIENT INFORMATION: SIDS SEQUENTIALLY STARTING AT (B)(6); ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT ANALYZER FOR MULTIPLE HEALTH FAIR PATIENTS. 163 PATIENT SAMPLES WERE PROCESSED, SIDS SEQUENTIALLY STARTING AT (B)(6). PER THE CUSTOMER, 90% OF PATIENT RESULTS WERE GREATER THAN 220 U/L; 60% OF PATIENT RESULTS WERE GREATER THAN 241 U/L (NORMAL RANGE: 125-220 U/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.