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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 Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 11/24/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 received a no delivery alarm that was resolved by changing their infusion set. The customer's blood glucose level at the time of the incident was 452 mg/dl. Customer treated the elevated blood glucose level with a bolus from her insulin pump. Customer was not able to troubleshoot at the time of the call. The infusion set is 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 Key7225544
MDR Text Key98471761
Report Number2032227-2018-01059
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 Date07/31/2020
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
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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