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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 05/07/2020
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
It was reported that emergency medical treatment was dispatched to the customer as a result of hypoglycemia and seizure on (b)(6) 2020 with blood glucose level of 4. 0 mmol/l/ customer stated that when the emergency medical treatment arrived the blood glucose level was 1. 2 mmol/l and the meter was showing 5. 8 mmol/l. Customer has been using insulin pump system within 48 hours of reported low blood glucose level. Customer was treated with food and glucose tablets. During hospitalization customer was treated with glucagon shots and food. Customer was unable to complete carelink upload. Customer did not allege that insulin pump was not over delivering. The insulin pump will not be returned for analysis.
 
Manufacturer Narrative
The information that provided with the initial report was incorrect. The correct information has been included with this report. (b)(4).
 
Event Description
It was reported that emergency medical service was dispatched as a result of hypoglycemia and seizure on (b)(6) 2020. The customer¿s blood glucose level was 4. 0 mmol/l. Customer stated that when the emergency medical service arrived, the customer's blood glucose level was 1. 2 mmol/l and the meter was showing 5. 8 mmol/l. Customer has been using insulin pump system within 48 hours of reported low blood glucose level. Customer was treated with food and glucose tablets. The customer was treated by the emergency medical service and was not transported to the hospital. The customer was treated with glucagon shots and food. Customer was unable to complete carelink upload. Customer did not allege that insulin pump was over delivering. The insulin pump will not be returned for analysis.
 
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
Type of DeviceARTIFICIAL 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 Key10073546
MDR Text Key191530458
Report Number2032227-2020-119872
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG2V0L8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/20/2020 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED INF SET
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