• 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 Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Hyperglycemia (1905); Weakness (2145); Diabetic Ketoacidosis (2364)
Event Date 10/15/2019
Event Type  Injury  
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
The customer reported via phone call that they were hospitalized for diabetic ketoacidosis on (b)(6) 2019.Blood glucose reading was 500 mg/dl.The customer stated that doctor took off insulin pump because it was not working.The customer was treated with intravenous drip at the hospital.Customer had symptoms such as weakness and no balance.Troubleshooting for the customer¿s high blood glucose was performed.The customer alleged that insulin pump was under delivering insulin.The reservoir will be returned for analysis.Unomed inf set.
 
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
*  00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*   00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
*   00777-3869
8185464805
MDR Report Key10360803
MDR Text Key201509286
Report Number2032227-2020-157097
Device Sequence Number1
Product Code FRN
UDI-Device Identifier20613994625476
UDI-Public(01)20613994625476(17)151009(10)H8443824
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 Other
Type of Report Initial
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/09/2015
Device Model NumberMMT-332A
Device Catalogue NumberMMT-332A
Device Lot NumberH8443824
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/28/2020
Initial Date FDA Received08/04/2020
Date Device Manufactured10/24/2012
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) Hospitalization;
Patient Age72 YR
Patient Weight160
-
-