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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problems Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); Blood Loss (2597)
Event Date 01/08/2020
Event Type  Injury  
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
The customer reported via phone call that they were experiencing high blood glucose.Customer was treated with insulin pump.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer did not allege insulin pump was under delivering.Customer stated insulin pump had insulin flow blocked alarm and insulin was exited.Customer stated blood on site.Troubleshooting was performed.The insulin pump will not be returned for analysis.
 
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Brand Name
630G INSULIN PUMP MMT-1715K 630G BLACK MG
Type of Device
ARTIFICIAL 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 Key9631675
MDR Text Key176395400
Report Number3004209178-2020-60454
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 Other
Type of Report Initial
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/22/2020
Initial Date FDA Received01/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
FRN-MMT-332,UNOMED INF SET
Patient Outcome(s) Other;
Patient Age27 YR
Patient Weight100
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