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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-876 SURET PRDGM 10PK 8MM32N SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MMT-876 SURET PRDGM 10PK 8MM32N SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-876
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 11/24/2016
Event Type  Injury  
Manufacturer Narrative
Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on october 1, 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 that they received a no delivery alarm. Customer's blood glucose level at the time of the incident was 473 mg/dl. Customer treated the elevated blood glucose level with a bolus from her insulin pump. Customer was able to troubleshoot. Customer disconnected at the quick release and attempted to perform a fixed prime. Customer reported that insulin did exit the infusion set tubing and the pump did not continue to alarm no delivery. Customer reported that the infusion set cannula was not bent the product is not expected to be returned.
 
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Brand NameINFST MMT-876 SURET PRDGM 10PK 8MM32N
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 Key7225419
MDR Text Key98466870
Report Number2032227-2018-01053
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 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/15/2020
Device Model NumberMMT-876
Device Catalogue NumberMMT-876
Device Lot Number5115467
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 Received11/24/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/01/2015
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: 01/29/2018 Patient Sequence Number: 1
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