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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SERTER MMT-7512NA 1 CLK SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED SERTER MMT-7512NA 1 CLK SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7512NA
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2019
Event Type  malfunction  
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.
 
Event Description
(b)(4). Initial notes: the customer reported difficulty in pressing the serter button. Inquired what led up to the complaint. Customer response: the customer was changing the sensor. One-press serter does not release sensor after insertion (guardian sensor 3) t/s per (b)(4). Explained possible causes. Adv customer of the correct insertion steps. Adv if buttons are re-pressed serter may re-attach to sensor and pull needle and sensor up and out along with serter. Customer did not follow correct steps to press and release buttons. Adv to return serter. Customer's outcome pertaining to the complaint: assisted customer with serter replacement. Ship: 1 serter/return: 1 serter.
 
Manufacturer Narrative
Please disregard the initial report as it was created and submitted in error.
 
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Brand NameSERTER MMT-7512NA 1 CLK
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
8185464805
MDR Report Key8859144
MDR Text Key153885776
Report Number2032227-2019-41116
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
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7512NA
Device Catalogue NumberMMT-7512NA
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 Received02/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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