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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIAGNOSTICS ACCU-CHEK INFORM II TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Catalog Number 05942861003
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The customer's meters and test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The investigation did not identify a product problem.The cause of the event could not be determined.
 
Event Description
The initial reporter received questionable glucose results from 2 accu-chek inform ii meters, serial numbers (b)(4).The initial meter result was 10.1 mmol/l.The same patient was tested on a different accu-chek inform ii meter and obtained the result of 6.5 mmol/l.The results were taken within 1 minute of each other.The same puncture site was used for both measurements.It is unknown which meter produced each result.
 
Manufacturer Narrative
The reporter's meters were returned for investigation.The test strips were not returned.The meters were tested with retention test strips lot 478646 exp 30-jun-2021: testing results for uu14390008: control ranges: sample 1: 2.8-4.0 mmol/l.Sample 2: 9.5-11.6 mmol/l.Sample 3: 19.5-23.8 mmol/l.Results: sample 1: 4.1, 4.1, 3.9 mmol/l.Sample 2: 10.4, 10.3, 10.4 mmol/l.Sample 3: 21.4, 21.8, 21.4 mmol/l.Testing results for uu14379836: control ranges: sample 1: 2.8-4.0 mmol/l.Sample 2: 9.5-11.6 mmol/l.Sample 3: 19.5-23.8 mmol/l.Results: sample 1: 4.0, 4.0, 3.9 mmol/l.Sample 2: 10.4, 10.2, 10.4 mmol/l.Sample 3: 21.7, 21.8, 22.2 mmol/l.Testing results for uu14189223: control ranges: sample 1: 2.8-4.0 mmol/l.Sample 2: 9.5-11.6 mmol/l.Sample 3: 19.5-23.8 mmol/l.Results: sample 1: 3.8, 3.8, 3.9 mmol/l.Sample 2: 10.3, 10.3, 10.3 mmol/l.Sample 3: 21.5, 21.5, 21.6 mmol/l.All returned results are within acceptable range.No information was provided in the complaint case that would point to a cause for the result discrepancy.
 
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Brand Name
ACCU-CHEK INFORM II TEST STRIPS
Type of Device
BLOOD GLUCOSE MONITORING TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10171266
MDR Text Key197093243
Report Number1823260-2020-01494
Device Sequence Number1
Product Code LFR
Combination Product (y/n)N
PMA/PMN Number
K121679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05942861003
Device Lot Number478646
Was Device Available for Evaluation? No
Date Manufacturer Received05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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