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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 Detachment Of Device Component (1104); Fracture (1260); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Bruise/Contusion (1754); Blood Loss (2597); Foreign Body In Patient (2687)
Event Date 07/01/2017
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. 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
The customer reported via phone call that his sensors were reading improperly and only lasting half of a day. The sensors would prematurely alarm change sensor. The patient's blood glucose at the time of incident is unknown. During troubleshooting the sensor was removed from the customer; it was confirmed that the sensor cannula was detached. The customer could not locate the cannula. The sensor fractured while inside of the customer's body. The sensor will be returned for analysis.
 
Manufacturer Narrative
Inspected 1 opened/used enlite sensor and found sensor cannula retracted inside sensor base. No broken or missing parts were observed during analysis. Analysis was unable to confirmed customer received sensor in said condition due to customer returned the sensor opened/used.
 
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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 Key6750856
MDR Text Key81418929
Report Number2032227-2017-31954
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,Followup
Report Date 09/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/16/2017
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device Lot NumberHG1WNA5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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