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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAS
Device Problem Premature Discharge of Battery (1057)
Patient Problem Insufficient Information (4580)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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
Information received by medtronic indicated that the insulin pump had an unexpected restart alarm and a cold reset was performed. The customer stated that the issue recurred after completing the rewind process and changing the batteries on the insulin pump. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-551NAS
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
7635140379
MDR Report Key12106190
MDR Text Key264321379
Report Number2032227-2021-163771
Device Sequence Number1
Product Code OZO
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 08/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551NAS
Device Catalogue NumberMMT-551NAS
Device Lot NumberA6551NASJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2017
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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