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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 Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 05/26/2019
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
The customer reported via phone call that the customer was hospitalized due to hypoglycemia on (b)(6) 2019. The customer¿s blood glucose level was 1. 3 mmol/ at the time of incident. The customer was assisted with troubleshooting. The customer did not mention nay treatments and symptoms related to low blood glucose event. Customer was using insulin pump system within 48 hours of reported low blood glucose event. Customer reports they contacted their health care professional regarding the low blood glucose. Customer stated that the insulin pump was not alleging over delivering. Customer stated insulin exited at the quick release. Customer reports basal rates were programmed accurately. Customer reports bolus wizard was programmed accurately. Customer was unable to complete carelink upload. The device will not be returned for analysis.
 
Manufacturer Narrative
The information that provided in date of event with the initial report was incorrect. The correct information has been included with this report. Additional information has been received which was not included with the initial report. The information has been provided with this report. (b)(4).
 
Event Description
It was reported via phone call the customer had visit to the emergency room due to low blood glucose level and seizure and troubleshooting did not mention about checking quick release, basal or bolus wizard settings.
 
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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 Key8657147
MDR Text Key146620429
Report Number2032227-2019-09602
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 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
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 NumberHG2S57E
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 Received07/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2018
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: 05/31/2019 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED INF SET
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