MAUDE Adverse Event Report: ROCHE DIABETES Care, INC. ACCU-CHEK GUIDE LINK; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number 118

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2021

Event Type  Injury  

Event Description

Accu-chek guide link blood glucose meter continually reporting an "electronic error" when attempting to use in any way.Recurring repeatedly over days and now over 2 weeks.Blood sugar reading vary markedly from test to test done within 5 mins.Manufacturer has me replacing batteries each time, which doesn't work.Cannot trust meter readings as cannot take test reliably.Testing often does not work at all.Fda safety report id# (b)(4).

• Brand Name: ACCU-CHEK GUIDE LINK
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ROCHE DIABETES Care, INC.
• MDR Report Key: 12142883
• MDR Text Key: 260958544
• Report Number: MW5102408
• 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
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 118
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Weight: 51