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

Model Number	PERFORMA
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested for investigation.
Event or Problem Description
We received an allegation of a display issue with an accu-chek performa meter.The reporter alleged the display was "not clear." the reporter replaced the battery and the meter powered on as expected.The reporter alleged the bottom half of the segments making up the time and date were not legible.The power button was not responding when attempting to complete a display check; the segments making up the results field could not be checked.The reporter did not know if there were missing segments from the results field.No patient results were misinterpreted.
Additional Manufacturer Narrative
No product was returned.Since the product was not returned for investigation, the cause of the event 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12761653
• Report Number: 1823260-2021-03245
• Device Sequence Number: 3170711
• Product Code: NBW
• UDI-Device Identifier: 00365702457102
• UDI-Public: 365702457102
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043474
• Number of Events Summarized: 1
• Summary Report (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): 12/17/2021

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 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: 10/12/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/17/2021
• 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 Sex: Unknown