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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE II; LANCING DEVICE
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ABBOTT DIABETES CARE INC FREESTYLE II; LANCING DEVICE Back to Search Results
Model Number 71582-01
Device Problem Material Separation (1562)
Patient Problems Hypoglycemia (1912); Loss of Vision (2139); Sweating (2444)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned and a valid serial number has not been provided.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.A tripped trend review was conducted for the reported complaint and lancing device, and no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer's daughter reported the body of the adc lancing device was separated in two pieces and the customer was therefore unable to test.Customer experienced "wetting" and was unable to see so the daughter provided unspecified treatment and transported the customer to the hospital where a reading of 42 mg/dl was obtained.Customer was diagnosed with hypoglycemia and treated with glucose intravenously.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Owen mumford (the manufacturer of the freestyle ii lancing device) investigated this issue and determined that the damage associated by cracking the body of the device along the seam line and dislodging the central connection is likely attributed to the user attempting to snap open the device at the join line, instead of the cap, causing the reported complaint mode.This issue is not confirmed due to use.The dhrs (device history review) for the freestyle lancing device ii were reviewed and the dhrs showed the freestyle lancing device ii passed all tests prior to release all pertinent information available to abbott diabetes care has been submitted.Additional information- section g3 has been updated to reflect current contact information.Section d4 (serial no) & h4 (device manufactured date) have been updated based on returned product download.
 
Event Description
Customer's daughter reported the body of the adc lancing device was separated in two pieces and the customer was therefore unable to test.Customer experienced "wetting" and was unable to see so the daughter provided unspecified treatment and transported the customer to the hospital where a reading of 42 mg/dl was obtained.Customer was diagnosed with hypoglycemia and treated with glucose intravenously.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE II
Type of Device
LANCING DEVICE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key10597183
MDR Text Key208914169
Report Number2954323-2020-06618
Device Sequence Number1
Product Code FMK
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71582-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Date Manufacturer Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age90 YR
Patient Weight57
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