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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 Failure to Charge (1085); Moisture or Humidity Problem (2986)
Patient Problem Hypoglycemia (1912)
Event Date 05/23/2015
Event Type  Injury  
Event Description
The customer reported via phone call that he had gone to the hospital a couple of times because of low blood glucose levels.His blood glucose level dropped to 40 mg/dl, 27 mg/dl, 17 mg/dl, and 15 mg/dl.The device was exposed to moisture as the label fell off the back.The transmitter would not charge.The device was not returned.
 
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 Key4837048
MDR Text Key19604062
Report Number2032227-2015-18583
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 05/23/2015
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 Model NumberMMT-7703NA
Device Catalogue NumberMMT-7703NA
Device Lot NumberA000282822
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/23/2015
Initial Date FDA Received06/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2012
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 Age68 YR
Patient Weight76
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