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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Hyperglycemia (1905); Lupus (1956); Renal Failure (2041); Ulcer (2274)
Event Date 07/23/2020
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
The customer reported via phone call that they were in emergency room service and admitted to hospital due to high blood glucose on (b)(6) 2020 with blood glucose of 186 mg/dl.Customer's other blood glucose value was 490 mg/dl.The customer experienced symptoms such as lupus, kidney issue and dehydration.The customer was wearing the insulin pump during the hospitalization.The insulin pump will not be returned for analysis.
 
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Brand Name
PUMP MMT-1715KM 630G 3ML BLACK MEDI
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 Key10513843
MDR Text Key206300599
Report Number2032227-2020-175110
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000643169873834
UDI-Public(01)000000643169873834
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 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG2FAWT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/02/2020
Initial Date FDA Received09/10/2020
Date Device Manufactured04/03/2018
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-332A-RSVR, UNOMED SET
Patient Outcome(s) Hospitalization;
Patient Age68 YR
Patient Weight61
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