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	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested for investigation.Replacement product was sent.The investigation is ongoing.
Event or Problem Description
There was an allegation of a display issue with an accu-chek inform ii meter, which led to a glucose result misinterpretation and an incorrect insulin dosage.It was reported that the meter was not damaged, but there were black splotches on the screen and in the results field.The customer performed a meter reset but the issue persisted.The customer reported that a meter glucose result was misinterpreted, 280 mg/dl instead of 230 mg/dl.The patient's nurse provided the incorrect insulin dosage.The customer did not know how much insulin or what kind of insulin was provided to the patient, the information was requested but not provided.It was reported the patient was "fine" and "there was not any harm or injury.".
Additional Manufacturer Narrative
The customer's meter was returned for an investigation.The investigation powered on the meter and a visual inspection showed several black lines and spots.One large area of lines/spots partially hides the first and second digits in the result screen, which was immediately visible to the user.The flaw was visible after turning on the device and permanently existed.There were no traces of an obvious mechanical impact visible on the housing of the device.The meter was disassembled for further investigation.The flex cable connection was checked and found to be correct.The returned display assembly was removed and replaced with a fully functional display assembly.The meter performed as expected with an exchanged display.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 the roche customer support center." updated medwatch fields: d9 and h3.

• 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: 13692933
• Report Number: 1823260-2022-00612
• Device Sequence Number: 11230065
• 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): 04/01/2022

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: 02/11/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/01/2022
• 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