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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7703NA
Device Problems Device Expiration Issue (1216); False Reading From Device Non-Compliance (1228)
Patient Problem Unspecified Infection (1930)
Event Date 09/01/2015
Event Type  Injury  
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. Reference manufacturer report number: 2032227-2015-46593.
 
Event Description
The customer reported via phone call that her sensor glucose was 40 mg/dl and her blood glucose was 200 mg/dl. The customer stated that the false readings happen often and that the last two sensors from her current box gave her issues as well. The customer also reported that she would develop a bad reaction from sensor usage. The customer stated a rash would form at the sensor site. The customer was provided an ointment to put around the sensor site by their healthcare provider. The transmitter was also used in conjunction with the sensor. Troubleshooting was not completed for the sensor glucose and blood glucose discrepancies since the customer declined it; however, the customer was advised that the discrepancies likely occurred due to the sensors being expired. Additionally, the customer had a high blood glucose into the upper 400 mg/dl range. The patient bolused but that did not seem effective. The customer mentioned that she has cancer and develops infections quickly. She had recently been taken off of certain medication and she suggests that they may have contributed to her high blood glucose event and to her not feeling well. No products were returned and two replacement sensors were shipped to the customer.
 
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Brand NameMINILINK TRANSMITTER MMT-7703NA
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key6764263
MDR Text Key81730048
Report Number2032227-2017-33803
Device Sequence Number1
Product Code MDS
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 Patient
Type of Report Initial
Report Date 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-7703NA
Device Catalogue NumberMMT-7703NA
Device Lot NumberA000323359
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/03/2017 Patient Sequence Number: 1
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