MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE STRIPS; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 71026-70

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

This is an initial final report. this issue does not meet reportability criteria; however, it is being reported to the fda as the complaint was received via user report.If product is returned, this case will be re-opened, an investigation will be conducted, and a follow-up report will be submitted after all investigation activities are complete.The device manufacturing 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

Abbott diabetes care received a medwatch report which reported the following information: a pharmacist reported that the customer experienced high reading issues and unspecified errors while using the adc freestyle libre sensor.It was further reported that ¿two lots giving her false reading and multiple errors, states her sugar was in the 40s but results were showing in the 70s¿.The user reported noted that the ¿type of report¿ is a malfunction and there was no report of self-treatment or third-party intervention.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: erica frank ; 1360 south loop road; alameda, CA 94502-7001 ; 5104242454
• MDR Report Key: 10861737
• MDR Text Key: 216932514
• Report Number: 2954323-2020-11170
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/21/2021
• Device Model Number: 71026-70
• Device Lot Number: 1117863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1