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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER; BLOOD GLUCOSE MONITORING DEVICE
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ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER; BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
Catalog Number 04882458001
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Patient Involvement (2645)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
The meter was requested for investigation.
 
Event Description
The initial reporter complained of a display issue with an accu-chek inform ii meter.The customer stated there were black lines in the display field of the device.This issue could affect the interpretation of patient results.The customer confirmed there has been no misinterpretation of results due to the issue.
 
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Brand Name
ACCU-CHEK INFORM METER
Type of Device
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 Key10904981
MDR Text Key243685421
Report Number1823260-2020-03013
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04882458001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2020
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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