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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2018
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. 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 the insulin pump had pump error. The customer¿s blood glucose level was 6. 2 mmol/l. The customer reported that the insulin pump had a broken force sensor was detected during seating and regular delivery alarm and insulin pump was exposed to moisture. The customer also reported that they does see a spot behind the screen. The customer reported that they are able to rewind the pump. The customer was advised that the insulin pump requires replacement and advised to discontinue use of the pump. Advised to revert to the backup plan. The insulin pump will not be returned for analysis.
 
Manufacturer Narrative
The insulin pump ws received with critical pump error due to moisture damage on the electronics assembly. The insulin pump was unable to perform the download due to moisture damage. The insulin pump was unable to perform the displacement test, rewind test, prime test, seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement, active current measurement and self test due to critical pump error. The insulin pump was received with moisture damage on the motor, vibrator motor or battery tube assembly. The device was received with a cracked retainer, cracked battery tube threads and cracked case corner on belt clip rails.
 
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
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 Key7576762
MDR Text Key110402299
Report Number3004209178-2018-78204
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG1SB8P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0955-2020

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