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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 Problems Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2020
Event Type  malfunction  
Manufacturer Narrative
The customer's meter and barcodes were requested for return.The customer's meter was returned for investigation.The investigation is ongoing.
 
Event Description
The initial reporter alleged that an accu-chek inform ii meter was not correctly scanning patient barcodes.The initial reporter alleged that 3 patient barcodes were incorrectly read and provided one example.The barcode on a patient wrist band should have been (b)(4) but when scanned read (b)(4).The customer stated they have 3 other meters on the floor that all read the barcodes correctly.
 
Manufacturer Narrative
The reporter's meter was returned for investigation.The customer meter barcode functionality was tested using sample barcodes.All barcodes were scanned correctly.No issue was found with the barcode scanning function of the meter.The alleged malfunction was not reproducible with the customer meter.The product performed according to the specifications.Medwatch fields d9 and h3 have been updated.
 
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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
MDR Report Key10979082
MDR Text Key220683265
Report Number1823260-2020-03156
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K012210
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 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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