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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK PERFORMA NANO; BLOOD GLUCOSE TEST SYSTEM
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ROCHE DIAGNOSTICS ACCU-CHEK PERFORMA NANO; BLOOD GLUCOSE TEST SYSTEM Back to Search Results
Catalog Number 06454364190
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Manufacturer Narrative
The meter was returned for investigation.When the meter was powered on, the segments and icons were faint.The meter was disassembled and found that the liquid-crystal display (lcd) was not properly seated on the printed circuit board (pcb).When the lcd was properly seated, the display appeared correctly.The lcd issue identified during the investigation was the cause of the display issue.
 
Event Description
There was an allegation of an intermittent display issue with an accu-chek performa nano meter.The customer stated the meter display is only showing the bottom half of the segments and the top half of the segments fade in and out.
 
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Brand Name
ACCU-CHEK PERFORMA NANO
Type of Device
BLOOD GLUCOSE TEST SYSTEM
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 Key12861951
MDR Text Key281194036
Report Number1823260-2021-03452
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K133741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number06454364190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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