MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® INFORM BASE; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 05060290001

Device Problems Melted (1385); Smoking (1585)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

The initial reporter complained of an issue with an accu-chek inform ii base unit.The customer alleged the base unit was smoking and the ethernet cable had melted inside the ethernet cord port.The base unit also showed signs of melting.

Manufacturer Narrative

The power source was fine.It was not necessary to evacuate the area.The base unit was requested for investigation.

Manufacturer Narrative

No product was returned.Since the product was not returned for investigation, the cause of the event could not be determined.

• Brand Name: ACCU-CHEK ® INFORM BASE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13567429
• MDR Text Key: 288659200
• Report Number: 1823260-2022-00444
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05060290001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1