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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-751LNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAS
Device Problems Premature Discharge of Battery (1057); No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2020
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 blank display.Customer stated the contacts on the battery cap were neither missing nor damaged.Customer stated battery compartment was neither damaged nor corroded.Customer stated the spring was neither damaged nor corroded.Customer also stated that the display did not returned after pump restart.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.
 
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Brand Name
530G INSULIN PUMP MMT-751LNAS
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
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
*   00777-3869
8185464805
MDR Report Key10912989
MDR Text Key218530042
Report Number2032227-2020-210882
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000643169507784
UDI-Public(01)000000643169507784
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 11/26/2020
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-751LNAS
Device Catalogue NumberMMT-751LNAS
Device Lot NumberA4751LNASJ
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2020
Initial Date FDA Received11/27/2020
Date Device Manufactured08/10/2017
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 Age55 YR
Patient Weight108
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