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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 No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496); Moisture or Humidity Problem (2986); Patient Device Interaction Problem (4001)
Patient Problem Pregnancy (3193)
Event Date 08/17/2019
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. 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 the insulin pump had blank display. The customer's blood glucose value was 233 mg/dl. Customer stated that the customer went to swimming and insulin pump exposed to moisture. Customer stated screen was flashing and also buttons were not responding. Customer advised the insulin pump will need to be replaced. Advised to discontinue use of the insulin pump and revert to a back-up plan. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Device passed the rewind test, prime or seating test, basic occlusion test and force sensor test. Device failed the sleep current test and active current test due to moisture damage on the electronic assembly. Blank display not confirmed. Device received with intermittent keypad unresponsiveness due to moisture damage on the electronic assembly. Missing segments or partial display not confirmed. Device failed the self test due to no back light caused by moisture damage on the electronic assembly. Device received with missing retainer and reservoir tube o-ring. Unable to perform the displacement test and p-cap or reservoir will not lock properly due to missing retainer. Device received with cracked belt clip rail case corner. Device received with pillowing keypad overlay. Device received with label damage or faded.
 
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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
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
8185464805
MDR Report Key8930600
MDR Text Key155524443
Report Number2032227-2019-52968
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,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/12/2018
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG205T8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2017
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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