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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 Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Priming Problem (4040)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2022
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 insulin pump was rejecting new batteries and and customer had to change the batteries in less than 7 days. Customer reported that the insulin pump was making grinding noise and was louder during rewind. Insulin pump also had no delivery alerts. No harm requiring medical intervention was reported. The device is not expected to be returned for analysis.
 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key13691650
MDR Text Key289895088
Report Number2032227-2022-121579
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
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG47VYP
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/30/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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