LACTATE DEHYDROGENASE
Received Jan 18, 2019
Report 1628664-2019-00040 · MDR key 8261501
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Manufacturing IncCatalog number
02P56-21
Lot number
99549UN18
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
THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2018-00152. THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED IN THE ORIGINAL REPORT. THIS REPORT WAS GENERATED TO DOCUMENT (B)(4) AS THE MANUFACTURE LOCATION. (B)(6). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, AN INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, DESIGN HISTORY RECORD (DHR) REVIEW, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR ISSUE OBSERVED BY THE CUSTOMER. THE DHR REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO DEFICIENCY OF THE CLINICAL CHEMISTRY LDH ASSAY, REAGENT LIST NUMBER 02P56, LOT 99549UN18, WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS FOR 2 PATIENTS (REFERENCE RANGE 125 TO 220 U/L): PATIENT 1: INITIAL 303, RETESTS: 238, 218, 300 AND 295 U/L; PATIENT 2: INITIAL 349, RETESTS: 214, 205 AND 206. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.