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

Model Number	PERFORMA
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated the meter was not physically damaged.The battery has been replaced.The meter was requested for investigation.
Event or Problem Description
The initial reporter complained of a display issue with an accu-chek performa professional meter.The customer stated the entire left side of the display screen is pixelated; the customer stated a result may not be clearly visible due to the issue.There has been no misinterpretation of results.The customer stated the meter cannot be used for testing in the current condition.
Additional Manufacturer Narrative
The customer did not return the meter for investigation.As no product was returned, a specific root cause could not be determined.

• Brand Name: ACCU-CHEK PERFORMA PROF 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: 15381509
• Report Number: 1823260-2022-02756
• Device Sequence Number: 14879986
• Product Code: NBW
• UDI-Device Identifier: 00365702457102
• UDI-Public: 00365702457102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043474
• 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): 10/20/2022

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: PERFORMA
• Device Catalogue Number: 05959551001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/20/2022
• 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