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

Catalog Number	04882458001
Medical Device Problem Codes	Display Difficult to Read (1181); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
There was a complaint of mistaken glucose results due to a pixelated display affecting two patients tested with an accu-chek inform ii meter.Patient 1¿s result from the meter at 7:56 am was mistaken for 136 mg/dl.The customer verified the initial meter reading from the software as 183 mg/dl.Patient 2¿s result from the meter at 9:30 am was mistaken for 186 mg/dl.The customer verified the initial meter reading from the software as 136 mg/dl.The customer used test strips lot number 480036 and the expiration date was requested but not provided.
Additional Manufacturer Narrative
The controls run on the day of the event were within range.The meter and test strips were requested for investigation.The test strips are not expected to be returned as they were used up and are no longer available.On a regular basis, accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The meter was returned for investigation.After powering on the meter the visual inspection of the display showed several black lines and spots.One large area of lines/spots partially hides the second and third digits in the result screen.This is immediately visible to the user.The flaw is visible after turning on the device and permanently exists.The returned display assembly was found to be defective.Per product labeling, "if you notice any issues with the display functionality (e.G.Unexpected lines/marks on the meter display) stop using the system and contact your roche representative.".

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12982945
• Report Number: 1823260-2021-03663
• Device Sequence Number: 17556589
• 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
• Report Date (Section B): 12/13/2021

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
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/13/2021
• 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 Age: 34 YR
• Patient Sex: Female