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

Model Number	PERFORMA
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The customer complained of missing segments from the display of the coaguchek xs meter which could impact the interpretation of the results.The customer stated that there were diagonal lines in the results field of the display.The customer performed a display check and verified missing segments in the results field.There was no allegation of an adverse event.There was no misinterpretation of the results.The suspect device was requested to be returned for investigation.
Additional Manufacturer Narrative
The customer¿s meter was returned for investigation.The functionality of the display was tested.Failure analysis indicated that the meter liquid crystal display (lcd) has multiple cracks running through the middle causing the display issue.Compression/gouge markings were found on the housing above the affected area.Due to the condition of the returned meter, it was concluded that the damage did not originate from the manufacturing process, and was a result of customer mishandling.

• 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
• MDR Report Key: 8041963
• Report Number: 1823260-2018-04089
• Device Sequence Number: 1683226
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1