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Model Number MMT-XXX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 05/20/2018
Event Type  Injury  
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 called and reported that their sensor was turned off and they had to use manual injections. The customer¿s blood glucose level was unknown at the time of the incident. The customer gave themselves too much insulin while using manual injections, as they had not done it in years. The customer started to shake. Troubleshooting was not completed. The customer was assisted by a rep when she got sick. The insulin pump will not be returned for analysis.
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Brand NameOTHER
Manufacturer (Section D)
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key7617680
MDR Text Key111621949
Report Number2032227-2018-06572
Device Sequence Number1
Product Code FOZ
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 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-XXX
Device Catalogue NumberMMT-XXX
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 Received05/20/2018
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: 06/19/2018 Patient Sequence Number: 1