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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KR
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Hypoglycemia (1912)
Event Date 09/01/2019
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 they were emergency room due to low blood glucose, on (b)(6) 2019 with blood glucose level was 20 mg/dl.Customer did not provided any information about the symptoms due to high blood glucose.Customer alleged insulin pump was over delivery.Customer reported they took much insulin.Customer was not feel ok with troubleshooting.The insulin pump will not be returned for analysis.
 
Event Description
Customer did not have high blood glucose on september 1, 2019.Customer reported having a low blood glucose of 20mg/dl.On september 1, 2019.Paramedics were dispatched and she was taken to the emergency room.Customer was then hospitalized.Customer said she might have given herself too much insulin.Pump was used at the time of the incident.It is unknown if sensor was used.Per svn 314203233, pump was returned back in 2019 but not for analysis.
 
Manufacturer Narrative
(b)(4).Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Information related to the summary has been updated and provided with this report in section b5.
 
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Brand Name
630G INSULIN PUMP MMT-1715KR 630G
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
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
7635140379
MDR Report Key14284453
MDR Text Key290797684
Report Number2032227-2022-186255
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000173036
UDI-Public(01)000000763000173036
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,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1715KR
Device Catalogue NumberMMT-1715KR
Device Lot NumberHG36YFQ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2019
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-UNK-RSVR, UNOMED SET.
Patient Outcome(s) Hospitalization;
Patient Age76 YR
Patient SexFemale
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