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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 Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553)
Event Date 12/29/2019
Event Type  Injury  
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
Nurse reported via phone call that customer was hospitalized on an unknown date due to diabetic ketoacidosis and hyperglycemia.Customer¿s blood glucose level was 1202 mg/dl at the time of incident.Customer¿s other blood glucose level was 500 mg/dl, 267 mg/dl, 529 mg/dl, 572 mg/dl, 231 mg/dl, 599 mg/dl, 487 mg/dl, 300 mg/dl, 600 mg/dl and 547 mg/dl.Customer was treated with insulin drip.Customer has been using insulin pump system within 48 hours of reported high blood glucose level.Customer experienced symptoms such as hypertension and slumped and altered mental state related to high blood glucose level.Customer was unable to complete carelink upload.Customer was not alleging insulin pump was under delivering.Customer stated that the drive support cap appears to be normal.The insulin pump will not 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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
8185464805
MDR Report Key9552225
MDR Text Key173735900
Report Number3004209178-2020-51351
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00763000161170
UDI-Public(01)00763000161170
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-751LNAS
Device Catalogue NumberMMT-751LNAS
Device Lot NumberA6751LNASJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2019
Date Device Manufactured09/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
FRN-MMT-326-RSVR, UNOMED SET
Patient Outcome(s) Hospitalization;
Patient Age63 YR
Patient Weight153
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