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

Catalog Number	08109257001
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.H3 other text : the customer is unable to return the device for evaluation.
Event or Problem Description
The caller reported that when he was driving, his blood glucose monitor started smoking and caught on fire.The customer reported that he threw the device out the window of the car.

• Brand Name: ACCU-CHEK ® GUIDE LINK
• Common Device Name: 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18146527
• Report Number: 3011393376-2023-02579
• Device Sequence Number: 20587170
• Product Code: OZP
• UDI-Device Identifier: 00365702702134
• UDI-Public: 00365702702134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 08109257001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 92 KG