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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED OTHER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-XXX
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2017
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
The customer reported via phone call that they had sensor discrepancies. The customer¿s sensor glucose reading from the reported event was 69 mg/dl while their blood glucose reading was 160 mg/dl. Troubleshooting was performed. Their current blood glucose level was 160 mg/dl. The customer stated that insulin delivery was suspended due to a low sensor glucose of 70 mg/dl. The suspend on low limit in the sensor setting was 70 mg/dl. They were advised to monitor and call back if issues persist. The product will not be returned for analysis.
 
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Brand NameOTHER
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key6798056
MDR Text Key82999944
Report Number2032227-2017-37208
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 08/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-XXX
Device Catalogue NumberMMT-XXX
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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