• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAP
Device Problems Premature Discharge of Battery (1057); Device Difficult to Program or Calibrate (1496)
Patient Problem Hyperglycemia (1905)
Event Date 04/15/2021
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 a keypad anomaly and unexpected restart error. Customer stated that they were unable to clear alarm. Customer stated that insulin pump was not working and stuck in rewind. Customer stated that time clock was visible and advances. No harm requiring medical intervention was reported. The insulin pump will not be returned for analysis.
 
Manufacturer Narrative
Device passed displacement test, self test and a21 alarm test. Device received with intermittent button response due to corroded keypad traces. No button error alarm during testing. No unexpected a21 alarm anomalies noted. Device received with cracked reservoir tube lip, cracked battery tube threads cracked case from display window corner, cracked case and missing end cap sticker. The test infusion set and reservoir does lock into place.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name530G INSULIN PUMP MMT-751NAP
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 Key11692900
MDR Text Key247077413
Report Number2032227-2021-137114
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 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAP
Device Catalogue NumberMMT-751NAP
Device Lot NumberA2751NAPJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-