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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAS
Device Problems Detachment of Device or Device Component (2907); Priming Problem (4040)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2022
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. Medtronic, inc. (medtronic) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned". These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
Information received by medtronic indicated that the insulin pump had issue during priming process. Customer stated that the drive support cap was protruded. No harm requiring medical intervention was reported. The customer will discontinue use of the device.
 
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Brand Name530G INSULIN PUMP MMT-751LNAS
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
tricha miles
18000 devonshire st.
northridge, CA 91325
7635140379
MDR Report Key14444142
MDR Text Key300304412
Report Number2032227-2022-192138
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000161170
UDI-Public(01)000000763000161170(10)A6751LNASJ
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
Report Date 05/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751LNAS
Device Catalogue NumberMMT-751LNAS
Device Lot NumberA6751LNASJ
Was Device Available for Evaluation? No
Date Manufacturer Received05/16/2022
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

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