MAUDE Adverse Event Report: ASSURE; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

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

Patient Problems Diarrhea (1811); Hypoglycemia (1912); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  malfunction  

Event Description

Several hypoglycemic episodes experienced despite blood sugar readings.Cramps and excessive diarrhea.Fda safety report id # (b)(4).

• Brand Name: ASSURE
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• MDR Report Key: 13541987
• MDR Text Key: 285728408
• Report Number: MW5107467
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2020
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose