MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK GUIDE ME; BLOOD GLUCOSE MONITORING DEVICE

Model Number 08387052001

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

It was reported that the guide me meter is burnt inside the battery compartment.The caller reported that the meter had been dropped in water, and that is when they noticed smoke.After further observation, they alleged the inside of the battery compartment is burnt.The caller stated that the meter and batteries were safe to touch.

• Brand Name: ACCU-CHEK GUIDE ME
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; 13000 south memorial parkway; na; huntsville AL 35807
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 10643034
• MDR Text Key: 210224013
• Report Number: 3011393376-2020-03644
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 08387052001
• Device Catalogue Number: 08387052001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 11/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR