MAUDE Adverse Event Report: ABBOTT FREESTYLE BLOOD GLUCOSE TEST STRIP

Lot Number 1354610

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.

• Brand Name: FREESTYLE BLOOD GLUCOSE TEST STRIP
• Type of Device: TEST STRIP
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 3599941
• MDR Text Key: 4088707
• Report Number: MW5034051
• Device Sequence Number: 1
• Product Code: NBW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/31/2014
• Device Lot Number: 1354610
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 91