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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008A
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Operates Differently Than Expected (2913)
Patient Problems Bruise/Contusion (1754); Skin Irritation (2076); Blood Loss (2597)
Event Date 05/05/2017
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 they had sensor discrepancy.  the sensor glucose value was 45 mg/dl while the blood glucose value was 120 mg/dl.  the insulin was suspended due to the low sensor glucose.  the low suspend limit in sensor setting was 60 or 65 mg/dl.  troubleshooting was performed.  they will be sent a replacement for their sensor.  the device will not be returned for analysis.
 
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Brand NameSENSOR ENLITE MMT-7008A
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
MDR Report Key6620809
MDR Text Key77243075
Report Number3004209178-2017-53536
Device Sequence Number1
Product Code OZO
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 06/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/20/2017
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device Lot NumberHG1T85E
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 Received05/09/2017
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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