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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAB
Device Problems Premature Discharge of Battery (1057); Device Difficult to Program or Calibrate (1496); Moisture or Humidity Problem (2986)
Patient Problem Hyperglycemia (1905)
Event Date 08/04/2021
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 had button error. Customer stated that they tried taking the battery out of the insulin pump because they could not clear it. Customer stated that the insulin pump also had compromised force sensor system alarm. The customer stated the device was exposed to moisture and they were not able to clear the alarm and rewind the insulin pump. No harm requiring medical intervention was reported. The insulin pump will not be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751NAB
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
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
7635140379
MDR Report Key12323356
MDR Text Key266603991
Report Number2032227-2021-180743
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 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAB
Device Catalogue NumberMMT-751NAB
Device Lot NumberA2751NABJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2013
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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