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

MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM

  • 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 MINIMED MINILINK TRANSMITTER; CGM Back to Search Results
Model Number MMT-7703NA
Device Problems Device Inoperable (1663); Moisture or Humidity Problem (2986)
Patient Problem Hyperglycemia (1905)
Event Date 06/14/2014
Event Type  malfunction  
Manufacturer Narrative
Unable to charge due to damaged pin.Unable to perform functional test due to charge anomaly.The insulin pump received with contamination to all pins.
 
Event Description
It was reported that the transmitter stopped working.Customer stated that the transmitter got wet.Customer put the transmitter in rice to dry out.Tried to test it without results.The blood glucose reading is 302 mg/dl.Customer is high due to celebrating father's day.Nothing further reported.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MINILINK TRANSMITTER
Type of Device
CGM
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 121
Manufacturer Contact
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key3939503
MDR Text Key12296015
Report Number2032227-2014-03939
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-7703NA
Device Catalogue NumberMMT-7703NA
Device Lot NumberA000297233
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/15/2014
Initial Date FDA Received07/16/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age63 YR
Patient Weight79
-
-