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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LITE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LITE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 70805-70
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Sweating (2444); Pallor (2468)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the freestyle lite meter were reviewed and the dhrs showed the fs freestyle lite meter passed all tests prior to release.Dhrs for freestyle strips were reviewed and the dhrs showed thefreestyle strips passed all tests prior to release.Retain testing was performed for freestyle strips and all units performed in the specification and passed.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date that the incident occurred is unknown.The date entered is based on the customer report of "(b)(6) 2020".All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer¿s wife reported the customer received a reading of 246 mg/dl on the adc blood glucose meter and consequently experienced symptoms described as ¿pale and sweaty¿ and was incapable of self-treating.The wife treated the customer with glucose tablets and then called the emergency service.An unspecified reading was obtained by the emergency service personnel and the customer was treated with a glucose gel patch and then taken to the hospital.The customer was hospitalized for 2 days and blood glucose was monitored however, no additional treatment information was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported meter has been returned and investigated with retained test strips.Visual inspection has been performed on the returned meter and no issues were observed.Meter powered on with button and test strips.Control solution testing has been performed.This issue is therefore not confirmed.
 
Event Description
A customer¿s wife reported the customer received a reading of 246 mg/dl on the adc blood glucose meter and consequently experienced symptoms described as ¿pale and sweaty¿ and was incapable of self-treating.The wife treated the customer with glucose tablets and then called the emergency service.An unspecified reading was obtained by the emergency service personnel and the customer was treated with a glucose gel patch and then taken to the hospital.The customer was hospitalized for 2 days and blood glucose was monitored however, no additional treatment information was reported.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LITE
Type of Device
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key10936000
MDR Text Key219317974
Report Number2954323-2020-12574
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00699073710260
UDI-Public00699073710260
Combination Product (y/n)N
PMA/PMN Number
K092602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2022
Device Model Number70805-70
Device Catalogue Number71026
Device Lot Number1119026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age78 YR
Patient Weight109
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