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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT FREESTYLE BLOOD GLUCOSE TEST STRIP

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ABBOTT FREESTYLE BLOOD GLUCOSE TEST STRIP Back to Search Results
Lot Number 1354610
Event Date 01/23/2014
Event Type  Injury  
Event Description

First, i was not notified of the freestyle test strip recall! when i found out last week ((b)(6) 2014), i phoned freestyle about why i could not get a refill for my (b)(6) daughter's test strips at (b)(4). (b)(4) said they were on back order but did not know why. They told me only certain lot numbers were affected and when i checked online, the 2 bottles i had left were not included in the recall so we kept using them. I was able to get a refill at another pharmacy. This morning, i checked my daughter's blood sugar with one of the old strips and it was 120. I then had her recheck with the new refill and it was 280 and a second test showed 260! that is over 100 points different!!! i had though she was having some great blood sugar readings but only a few were too low, so i had not been concerned until this morning with these readings with the new strips! i am afraid she will have a high a1c on her return appointment in (b)(6)! reason for use: type 1 diabetes.

 
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Brand NameFREESTYLE BLOOD GLUCOSE TEST STRIP
Type of DeviceTEST STRIP
Manufacturer (Section F)
ABBOTT
Manufacturer (Section D)
ABBOTT
Device Event Key3622755
MDR Report Key3599941
Event Key3496476
Report NumberMW5034051
Device Sequence Number1
Product CodeNBW
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 01/23/2014
2 DeviceS WERE Involved in the Event:1 2 
1 Patient Was Involved in the Event
Date FDA Received01/24/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device EXPIRATION Date08/31/2014
Device LOT Number1354610
Was Device Available For Evaluation? Yes
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 01/24/2014 Patient Sequence Number: 1
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