• 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 Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 09/14/2020
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
It was reported that the customer experienced hypoglycemia.The customer blood glucose level was 32 mg/dl.Customer stated that she had seizure today and mostly sleeping the whole day.Customer had symptoms such as mental confusion and belligerence numbness of face.The customer was assisted with troubleshooting.The customer was treated with food and glucose tablets other glucagon for low blood glucose.Customer was using insulin pump system within 48 hours of reported low blood glucose event.Customer stated that they did alleging insulin pump for over delivery, because they had low while pump was suspended.Customer stated that drive support cap was normal.Customer was offered troubleshooting for battery issues and declined for battery issue.The insulin pump will be returned and reservoir 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
*  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 Key10598973
MDR Text Key208917689
Report Number2032227-2020-183823
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 09/29/2020
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? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-332A
Device Catalogue NumberMMT-332A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/18/2020
Initial Date FDA Received09/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNOMED SET
Patient Outcome(s) Other;
Patient Age38 YR
Patient Weight130
-
-