• 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. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

  • 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. RESERVOIR 3ML MMT-332A; PUMP, INFUSION Back to Search Results
Model Number MMT-332A
Device Problems Bent (1059); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 07/14/2017
Event Type  Injury  
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.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 they experienced a high blood glucose level of 442 mg/dl.The customer reported high blood glucose levels, no delivery alarms and 10 infusion set bent cannulas.The customer received the no delivery alarm and blood glucose level stated to rise 103 mg/dl.The customer had no symptoms and treated with a bolus from the insulin pump.The customer was unable to complete troubleshooting due to a complete set change.The insulin pump will not be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESERVOIR 3ML MMT-332A
Type of Device
PUMP, INFUSION
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 Key7649687
MDR Text Key112702248
Report Number3004209178-2018-86549
Device Sequence Number1
Product Code FRN
UDI-Device Identifier20613994625476
UDI-Public(01)20613994625476(017)20190317
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 Patient
Type of Report Initial
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/17/2019
Device Model NumberMMT-332A
Device Catalogue NumberMMT-332A
Device Lot NumberHG0XYZ1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/14/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age69 YR
Patient Weight181
-
-