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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC LITE METER FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC LITE METER FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 70805-70
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)
Event Date 10/19/2023
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the adc device.The customer reported encountering an error 14 message on their meter and was unable to obtain readings.As a result, the customer experienced hypoglycemia with symptoms described as sweating, lightheadedness, hard time walking, weakness, and dizziness.The customer was able to self-treat with chocolate candy and then they were seen at a hospital where they were provided sugar water for treatment.No further treatment or medication was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhr(device history review) for the freestyle lite meter were reviewed and the dhrs showed the freestyle lite meter passed all tests prior to release.Dhrs for the freestyle strips were reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing has not been performed for freestyle strips since strips was expired.Meter (b)(6) has been returned and investigated with returned test strips.Visual inspection has been performed on the returned meter and no issues were observed.Meter powered on with button and with strip insertion.Control solution testing was performed and no issues were observed.All results were within range specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the adc device.The customer reported encountering an error 14 message on their meter and was unable to obtain readings.As a result, the customer experienced hypoglycemia with symptoms described as sweating, lightheadedness, hard time walking, weakness, and dizziness.The customer was able to self-treat with chocolate candy and then they were seen at a hospital where they were provided sugar water for treatment.No further treatment or medication was reported.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
LITE METER FREESTYLE
Type of Device
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key18136201
MDR Text Key328106946
Report Number2954323-2023-49902
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00699073708052
UDI-Public00699073708052
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/31/2023
Device Model Number70805-70
Device Lot Number1162581
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received12/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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