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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755K PUMP 630G 3ML BK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755K PUMP 630G 3ML BK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1755K
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/11/2018
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that insulin pump had critical pump error alarm.The blood glucose level was 163 mg/dl at the time of incident.The insulin pump will be returned for analysis.
 
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Brand Name
KIT MMT-1755K PUMP 630G 3ML BK MG
Common Device Name
ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
MDR Report Key8294838
Report Number3004209178-2019-49939
Device Sequence Number1527493
Product Code OZO
UDI-Device Identifier00643169752726
UDI-Public(01)00643169752726
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/31/2019
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
Operator of Device Lay User/Patient
Device Model NumberMMT-1755K
Device Catalogue NumberMMT-1755K
Device Lot NumberHG1ZBK2
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2018
Initial Report FDA Received Date01/31/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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