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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II BASE UNIT LIGHT; BLOOD GLUCOSE MONITORING DEVICE
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ROCHE DIAGNOSTICS ACCU-CHEK INFORM II BASE UNIT LIGHT; BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
Catalog Number 05984840001
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer complained that the accu-chek inform ii base unit with serial number (b)(4) had damage to the charging contacts.The customer stated that the left base unit charging contact appear burnt as it is blackened with some substance visible.The customer cleans the unit with clorox bleach wipes allowing them to air dry.Product labeling stated "dry the base unit surfaces thoroughly with a soft cloth or gauze after cleaning." the customer stated that there was no damage to any other components.There was no adverse event.The device was requested for investigation.
 
Manufacturer Narrative
The customer base unit was returned for investigation.During the investigation, it was confirmed that the base unit has corroded charging contacts.Contacts are darkened due to the corrosion.Melting /burning was not observed.
 
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Brand Name
ACCU-CHEK INFORM II BASE UNIT LIGHT
Type of Device
BLOOD GLUCOSE MONITORING DEVICE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7605305
MDR Text Key111174465
Report Number1823260-2018-01924
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K121679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05984840001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Date Manufacturer Received05/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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