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

Model Number INFORM II

Device Problem Circuit Failure (1089)

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

Event Date 09/22/2021

Event Type  malfunction  

Event Description

The initial reporter complained of an issue that occurred in the past with an accu-chek inform ii base unit.The date of the event is an approximation; the reporter stated the issue occurred one year ago.The customer alleged the base unit was not charging and the charging contacts of the base unit appeared "scorched" and "burnt.".

Manufacturer Narrative

The base unit was requested for an investigation; however, the base unit is no longer available to return as the customer has already replaced it.

Manufacturer Narrative

The customer did not return the product for investigation.Since no product was returned, the cause of the event could not be determined.

• Brand Name: ACCU-CHEK INFORM II BASE UNIT
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15618775
• MDR Text Key: 307033104
• Report Number: 1823260-2022-03210
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 04015630942473
• UDI-Public: 04015630942473
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121679
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFORM II
• Device Catalogue Number: 07671717190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• 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