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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 Hypoglycemia (1912)
Event Date 05/07/2016
Event Type  Injury  
Manufacturer Narrative
Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 2017. Subsequently, medtronic diabetes conducted a two 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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
Customer reported via phone call that they experienced a bent infusion set needle. Customer's blood glucose level was 29 mg/dl at the time of the incident. The customer did not troubleshoot the low blood glucose level or the bent infusion set needle. No product is being 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 Key7175917
MDR Text Key96760169
Report Number2032227-2018-00520
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 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2017
Device Model NumberMMT-975T
Device Catalogue NumberMMT-975T
Device Lot Number002955666T
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 Received05/12/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/15/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
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