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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INPEN

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MEDTRONIC MINIMED INPEN Back to Search Results
Model Number IN-PEN
Device Problem Computer Software Problem (1112)
Patient Problem Insufficient Information (4580)
Event Date 09/05/2021
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
The customer reported via phone call that there was an inaccuracy between the dose intended and dose recorded. The dose was greater than 1. 0 unit of insulin. No harm requiring medical intervention was reported. The insulin pen will not be returned for analysis.
 
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Brand NameINPEN
Type of DeviceINPEN
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
tricha miles
18000 devonshire st.
northridge, CA 91325-1219
7635140379
MDR Report Key12453321
MDR Text Key273321818
Report Number2032227-2021-191337
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIN-PEN
Device Catalogue NumberIN-PEN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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