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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK PERFORMA METER; BLOOD GLUCOSE MONITORING DEVICE
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ROCHE DIAGNOSTICS ACCU-CHEK PERFORMA METER; BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
Model Number PERFORMA
Device Problem Display Difficult to Read (1181)
Patient Problem No Patient Involvement (2645)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
The device was requested for investigation.
 
Event Description
The initial reporter complained of a display issue with an accu-chek performa meter.The customer stated there were black lines on the display screen affecting the results field.The black lines make the results unclear.No misinterpretation of results occurred due to the display issue.
 
Manufacturer Narrative
The meter was returned for investigation.Sections d10 and h3 were updated.The meter was contaminated by liquid residue and debris on the printed circuit board and meter housing under the lcd cover which can cause the display issue observed.The investigation determined this contamination was due to customer mishandling and did not originate from the manufacturing process.
 
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Brand Name
ACCU-CHEK PERFORMA METER
Type of Device
BLOOD GLUCOSE MONITORING DEVICE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10240340
MDR Text Key200439224
Report Number1823260-2020-01617
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K043474
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPERFORMA
Device Catalogue Number04680421002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Date Manufacturer Received06/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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