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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM

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MEDTRONIC MINIMED MINILINK TRANSMITTER; CGM Back to Search Results
Model Number MMT-7703NA
Device Problems Improper or Incorrect Procedure or Method (2017); Charging Problem (2892)
Patient Problem Hypoglycemia (1912)
Event Date 03/20/2015
Event Type  Injury  
Event Description
It is reported that a customer was hospitalized on (b)(6) 2015 at 1:00am for a low blood glucose level of 31 mg/dl.The customer stated that they had not eaten in many hours prior to the low blood glucose.The customer mentioned that their sensor was not holding charge, but they declined trouble shooting the issue.No further information was provided.
 
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
 
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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 Key4714239
MDR Text Key16307382
Report Number2032227-2015-13241
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
Report Date 04/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-7703NA
Device Catalogue NumberMMT-7703NA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2011
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 Outcome(s) Hospitalization;
Patient Age56 YR
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