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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-975T
Device Problem Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 09/18/2015
Event Type  Injury  
Manufacturer Narrative
Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 2014. Subsequently, medtronic diabetes conducted a one year retrospective review of complaints. This event was retrospectively identified to be reportable based on the revised mdr reportability criteria. Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
Customer reported via phone call that they were hospitalized due to a high blood glucose level. Customer is reporting a past event. Customer reported that her blood glucose level at the time of the hospitalization was over 500 mg/dl. Customer's blood glucose level at the time of the call was 382 mg/dl. Customer reported experiencing a heart attack that caused the hospitalization. Customer reported finding a bent cannula on two infusion sets at the time of the heart attack, elevated blood glucose level, and hospitalization. The product is expected to be returned.
 
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Brand NameINFST MM T-975T MIO 2PK 9MM 32IN CLEAR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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 Key7131764
MDR Text Key95317441
Report Number2032227-2017-74907
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Model NumberMMT-975T
Device Catalogue NumberMMT-975T
Device Lot Number5106192
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2015
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

Patient Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1
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