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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT FREESTYLE FREEDOM LITE METER
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ABBOTT FREESTYLE FREEDOM LITE METER Back to Search Results
Model Number CEGT337-M7457
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014 - lab tests at (b)(6) shows glucose was 116 - freestyle freedom lite meter showed 131 (fasting).On (b)(6) 2014 - health screen summit health at (b)(6) glucose 197 - freestyle freedom lite meter showed 106 (non fasting).On (b)(6) 2014 - lab test at (b)(6) shows glucose was 104 - freestyle freedom lite meter showed 127 (fasting).On (b)(6) 2014 - health screen by summit health at (b)(6) glucose 76 - freestyle freedom lite meter showed 101 (non fasting).The sample of blood used on the strip was the same as lab/screening personnel used for testing.
 
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Brand Name
FREESTYLE FREEDOM LITE METER
Type of Device
FREESTYLE FREEDOM LITE METER
Manufacturer (Section D)
ABBOTT
MDR Report Key4128596
MDR Text Key4944529
Report NumberMW5038371
Device Sequence Number1
Product Code LFR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 09/24/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/24/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCEGT337-M7457
Patient Sequence Number1
Treatment
VITAMIN D - 2000 UNITS 1X DAY; IRON-OVER COUNTER 1 X DAY (EVENING); BENZONATATE 200MG (TESSALON) 1 EVERY 8 HRS; CENTRUM MULTIVITAMIN (ADVANCED FORM) 1 X DAY; FLONASE NASAL SPRAY 1-2 SPRAYS PER NOSTRIL:; SYSTANE BALANCE - EYE DROPS 1XDAY; SINGULAIR 10MG (MONTELUKAST) 1 TAB X DAY (NIGHT); SYMBICORT 160/4.5 INHALER 2 PUFFS IIN MORN/NIGHT; SYNTHOID 25MCG 1 PER DAY (MORNING); SYSTANE BALANCE 1 DROP BOTH EYES MORN/NIGHT; METFORMIN HCI ER 500MG 4 TABLETS 2/MORN/2BEDTIME; NITROSTAT 0.4MG SL TAB 1 ONSET OF PAIN UNDERTONGUE; CHOL OFF COMP 3/2X PER DAY; PROMETHAZINE-CODINE SYRUP 2 TSP EVERY 4 HRS; KRILL OIL 1 PER DAY (MORN); LANSOPRAZOLE DELAYED REL CAP 1 DAILY BEFORE MEAL; (MORN/NIGHT) AS NEEDED: 4+ YRS; COQ10 100MG 1 X DAY (MORN)
Patient Age61 YR
Patient Weight70
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