MalfunctionNUI
TRUETRACK
Received Feb 21, 2014 · Event occurred Mar 12, 2014
Report 1052693-2014-00117 · MDR key 3802525
Device
Generic name
Blood Glucose System
Manufacturer
Home Diagnostics, Inc.Model number
TRUETRACKCatalog number
A4H01-81
Lot number
RP4145
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). PRODUCT NOT YET RETURNED.
Description of Event or Problem
CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER NORMALLY IS 115-130 MG/DL TWO HOURS AFTER BREAKFAST. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT GIVEN (344) AND THE NORMAL RESULT (115) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.
Remedial action
- Replace