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

Catalog Number	04882458001
Medical Device Problem Codes	Circuit Failure (1089); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's meter was requested for an investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of blackened charging contacts on the base unit of the accu-chek inform ii meter docking station.It was reported that there were no signs of melted plastic on the base or any damage with the meters docked in the base.
Additional Manufacturer Narrative
The base unit was returned for investigation.Visual examination of the base unit determined there were no signs of melting or burning.Corrosion was observed on the charging pins.Mishandling by the customer is the cause of the corrosion on the charging pins.

• Brand Name: ACCU-CHEK ® INFORM METER
• 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: 15226665
• Report Number: 1823260-2022-02441
• Device Sequence Number: 12265275
• Product Code: NBW
• UDI-Device Identifier: 04015630945757
• UDI-Public: 4015630945757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012210
• 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
• Report Date (Section B): 09/02/2022

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 Catalogue Number: 04882458001
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/02/2022
• 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