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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-751NAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAP; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAP
Device Problems Premature Discharge of Battery (1057); Break (1069); Priming Problem (4040)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2021
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
 
Event Description
Information received by medtronic indicated that the insulin was squirting out from infusion set.Customer stated that the insulin pump had an insulin pump error.Customer stated that insulin pump had crack where battery goes.No harm requiring medical intervention was reported.The insulin pump will not be returned for analysis.
 
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Brand Name
530G INSULIN PUMP MMT-751NAP
Type of Device
ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*  00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*   00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
*   00777-3869
7635140379
MDR Report Key12216820
MDR Text Key265239193
Report Number2032227-2021-171577
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000643169404335
UDI-Public(01)000000643169404335
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 Other
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMMT-751NAP
Device Catalogue NumberMMT-751NAP
Device Lot NumberA2751NAPJ
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/14/2021
Initial Date FDA Received07/23/2021
Date Device Manufactured10/14/2013
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 Age38 YR
Patient Weight59
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