LACTATE DEHYDROGENASE
Received Jul 8, 2020 · Event occurred Jun 8, 2020
Report 3016438761-2020-00116 · MDR key 10248374
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Laboratories (irving Ia/cc)Model number
2P56-21Catalog 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
PT#1; PT#2; (B)(6) YEARS; (B)(6) YEARS; FEMALE; MALE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER. DEVICE EVALUATION: THE EVALUATION OF THE CUSTOMER ISSUE FOR SIMILAR COMPLAINTS BY LOT NUMBER COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. A REVIEW FOR TRENDS BY PRODUCT CODE FOUND NO TRENDS RELATED TO THIS ISSUE. A REVIEW OF LABELING FOUND THE ISSUE IS ADEQUATELY ADDRESSED. A REVIEW OF THE CAPA DATABASE FOUND NO TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. BASED ON ALL AVAILABLE INFORMATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Description of Event or Problem
ON (B)(6) 2020 CUSTOMER PROVIDE ADDITIONAL INFORMATION REGARDING THEIR STATEMENT OF FALSE ELEVATED ARCHITECT LACTATE DEHYDROGENASE (LDH) ASSAY RESULTS FOR 2 PATIENTS. THE CUSTOMER PROVIDED: PT#1: (B)(6) YEAR OLD FEMALE: INITIAL = 195 U/L; REPEAT 714, 200 U/L; PT#2: (B)(6) YEAR OLD MALE: INITIAL = 244 U/L; REPEAT 331 U/L, 276 U/L (REF RANGE: 140 TO 280 U/L). IT WAS ALSO ADDED THAT ALL RESULTS ARE FROM THE SAME SAMPLE MEASURED WITHOUT FURTHER SAMPLE TREATMENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.