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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR HSA; CGM
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MEDTRONIC MINIMED SENSOR HSA; CGM Back to Search Results
Model Number MMT-7003A
Device Problem Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2014
Event Type  malfunction  
Event Description
It was reported that the sensors from a particular lot had incidents of skipped and missing data.Sensors will be replaced.Nothing further reported.
 
Manufacturer Narrative
Reliability analysis inspected 2 opened/used sensor and performed bicarbonate buffer test.Both sensors passed with accurate readings.Inspected 3 sealed sof-sensors and performed bicarbonate buffer test.All 3 sensors failed due to low readings.
 
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Brand Name
SENSOR HSA
Type of Device
CGM
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 121
Manufacturer Contact
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key4090509
MDR Text Key4762746
Report Number2032227-2014-23159
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-7003A
Device Catalogue NumberMMT-7003A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/08/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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