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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE INSULINX; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE INSULINX; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71143-70
Device Problem Packaging Problem (3007)
Patient Problem Hyperglycemia (1905)
Event Date 01/03/2018
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
Customer reported a packaging issue, stating his adc freestyle precision neo meter kit contained an adc freestyle insulinx meter.Customer further reported he attempted to test using the meter and his freestyle precision neo test strips but was unsuccessful and had to be seen at a hospital.At the hospital, customer reported he was "given 3 injections, one of which he thinks is insulin".No additional information was provided as customer declined to continue troubleshooting.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhr(s) (device history review) for the freestyle insulinx meter and freestyle precision neo meter were reviewed and the dhr(s) showed the freestyle insulinx meter and freestyle precision neo meter passed all tests prior to release.The dhr (packout) report verified that the insulinx meter was packed 26-may-2016 and the freestyle precision neo meter was packed on 07-jul-2017, over a year apart from each other.There is no indication these meters were packed in the incorrect packages.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.This also serves as a correction report.Model no and pma/510(k) were incorrectly documented in the initial report.Both pma/510(k) and model no have been updated.
 
Event Description
Customer reported a packaging issue, stating his adc freestyle precision neo meter kit contained an adc freestyle insulinx meter.Customer further reported he attempted to test using the meter and his freestyle precision neo test strips but was unsuccessful and had to be seen at a hospital.At the hospital, customer reported he was "given 3 injections, one of which he thinks is insulin".No additional information was provided as customer declined to continue troubleshooting.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE INSULINX
Type of Device
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7232487
MDR Text Key98730874
Report Number2954323-2018-00770
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152328
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 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71143-70
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight71
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