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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
The customer's meter was requested and returned for an investigation.The investigation is ongoing.
 
Event Description
The initial reporter complained of a malfunction of the wireless connection feature on an accu-chek inform ii meter.The customer's allegation was that the wireless connection assigned a patient's result to a previously tested patient.Prior to meter testing, the customer confirmed each patient name was correct.Patient a's meter test was performed, and the meter result was displayed for patient a.Patient b's meter test was performed, but the meter result was displayed for patient a.Patient c's meter test was performed, and the meter result was displayed for patient c.Patient d's meter test was performed, but the meter result was displayed for patient c.The customer noticed the issue and rescanned the barcodes for patient b and patient d.The correct patient information was provided within the meter.The customer performed repeat testing for patient b and patient d.The repeat results were displayed correctly within the meter.
 
Manufacturer Narrative
The customer's meter was returned for investigation.An analysis of the patient results was performed.On (b)(6) 2020 5 measurements were made by operator id (b)(4).Three consecutive measurements on patient a and then two measurements on patient b.The individual measurements of patient a are close together as well as those of patient b.Since the mean values of the results of patient a and patient b are very far apart, no confusion or saving of a measurement at the previous patient could have taken place.Measurements from a patient c or d were not available on that day.The error could not be reproduced, no error could be found.The meter works within specification section h3 was 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 Key10750659
MDR Text Key213678191
Report Number1823260-2020-02696
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer10/27/2020
Initial Date Manufacturer Received 08/18/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received08/18/2020
Supplement Dates FDA Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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