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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008A
Device Problems Break (1069); Calibration Problem (2890)
Patient Problems Bruise/Contusion (1754); Hypoglycemia (1912)
Event Date 03/24/2021
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
Svn: (b)(4). Start date of the sensor. Start hour of the sensor. Sensor start missing reason: does not know. Location of sensor insertion: na. Date of sensor alert. Hour of sensor alert. Sensor alert missing reason: does not know (b)(6) 2021 09:54:08 pst (b)(6) per (b)(6): customer reported by e-mail that sensor is presenting calibration not accepted and change sensor alert with less than 3 days customer also reported that when inserted the sensor the insertion site presented a bruise customer also reported a low bg event 23mg/dl we tried to contact the customer without success to troubleshoot complaint was referred to the clinical specialist in order to resolve the issue *no further details given* customer; (b)(6) no rma requested date of report*: (b)(6) 2021. (b)(4).
 
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Brand NameSENSOR ENLITE MMT-7008A
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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 Key11592465
MDR Text Key252022490
Report Number2032227-2021-129322
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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