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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SMARTPHONE IOS APP: PUMP CONNECT; SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED SMARTPHONE IOS APP: PUMP CONNECT; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-6102
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2022
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
Information received by medtronic indicated that the mobile app was unresponsive.No harm requiring medical intervention was reported.The device will not be returned for analysis.
 
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Brand Name
SMARTPHONE IOS APP: PUMP CONNECT
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
tricha miles
18000 devonshire st.
northridge, CA 91325
7635140379
MDR Report Key15319592
MDR Text Key305354752
Report Number2032227-2022-318707
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
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 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-6102
Device Catalogue NumberMMT-6102
Was Device Available for Evaluation? No
Date Manufacturer Received07/31/2022
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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