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

Model Number	INFORM II
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter and base were requested for investigation.Replacement product was sent.
Event or Problem Description
There was an allegation of a blackened charging contact on an accu-chek inform ii meter charging base.The initial reporter alleged that there are no signs of melted plastic on the base and the meter shows no signs of burning.
Additional Manufacturer Narrative
Fields d9 and h3 were updated.The meter and base were provided for investigation.The investigation found that the base unit had corroded charging contacts.Corrosion on the charging contacts can prevent the full connection between the meter and base and can cause charging and download issues.The investigation determined that the root cause of the event is consistent with incomplete cleaning and disinfection and not making sure the base and meter are completely dry prior to docking.Per product labeling, "dry the meter thoroughly with a dry cloth or gauze.Visually verify that no solution is seen anywhere on the meter at the completion of cleaning and disinfecting.Ensure that the meter is thoroughly dried after cleaning.".

• 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: 15854487
• Report Number: 1823260-2022-03756
• Device Sequence Number: 12066252
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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: 11/03/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/22/2022
• 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