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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 Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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

Information received by medtronic indicated that the sensor needle was broken. No harm requiring medical intervention was reported. The sensor 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
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
8185464805
MDR Report Key10910635
MDR Text Key218665860
Report Number2032227-2020-210477
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeCH
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 11/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/27/2021
Device MODEL NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device LOT NumberHG4HHR7
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/31/2020
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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