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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 70914-70
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Collapse (2416); Loss of consciousness (2418)
Event Date 05/15/2020
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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle freedom lite meter were reviewed and the dhrs showed the freestyle freedom lite meter passed all tests prior to release.The dhrs (device history review) for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.Retain testing was performed for freestyle strips and all units performed in specification and passed.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported that on (b)(6) 2020, he received unspecified high readings on his adc blood glucose meter.Customer further reported he ¿was in a state of delirium, nothing was right, collapsed and subsequently lost consciousness.Customer was rushed to hospital where a laboratory reading of 24 mg/dl was obtained.Customer was administered a shot of "lantus" to control his glucose level.It should be noted that the treatment reported is not consistent with the laboratory reading.Customer was hospitalized until (b)(6) 2020 due to low sugar level.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The reported meter and strips have been returned and investigated.Visual inspection has been performed and no issues were observed.The meter powered on with button depression and with insertion of strip.Performed control solution test and all results were satisfactory.No malfunction or product deficiency was identified.
 
Event Description
Customer reported that on (b)(6) 2020, he received unspecified high readings on his adc blood glucose meter.Customer further reported he ¿was in a state of delirium, nothing was right, collapsed and subsequently lost consciousness.Customer was rushed to hospital where a laboratory reading of 24 mg/dl was obtained.Customer was administered a shot of "lantus" to control his glucose level.It should be noted that the treatment reported is not consistent with the laboratory reading.Customer was hospitalized until (b)(6) 2020 due to low sugar level.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE FREEDOM 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 Key10213021
MDR Text Key197111324
Report Number2954323-2020-04436
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00699073710260
UDI-Public00699073710260
Combination Product (y/n)N
PMA/PMN Number
K070850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2022
Device Model Number70914-70
Device Catalogue Number71026
Device Lot Number1114230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
Patient Weight76
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