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

Model Number	INFORM II
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of an issue with an accu-chek inform ii base unit.The customer alleged the base unit was not charging and the charging contacts of the base unit appeared "scorched" and "burnt.".
Additional Manufacturer Narrative
The base unit was requested for investigation.
Additional 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.
Additional Manufacturer Narrative
The device was received for investigation.A visual examination was performed and corrosion was observed on one of the charging contacts.This corrosion can affect the charging capabilities of the base unit.The investigation determined the corrosion was consistent with a customer handling issue (improper cleaning).The investigation did not identify a product problem.

• Brand Name: ACCU-CHEK INFORM II BASE UNIT
• Common Device Name: 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: 15619593
• Report Number: 1823260-2022-03209
• Device Sequence Number: 6345259
• Product Code: NBW
• UDI-Device Identifier: 04015630942473
• UDI-Public: 04015630942473
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

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: Health Professional
• Device Model Number: INFORM II
• Device Catalogue Number: 07671717190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 11/11/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/08/2022; 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown