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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-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KL
Device Problems Device Alarm System (1012); Display or Visual Feedback Problem (1184); Patient Device Interaction Problem (4001)
Patient Problem Bruise/Contusion (1754)
Event Date 01/18/2019
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that the insulin pump had a flashing display.The customer¿s blood glucose level was 142 mg/dl at the time of the incident.The customer was assisted with troubleshooting and customer reports that the screen was white and cant stop beeping.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The customer was advised the insulin pump will be replaced as per troubleshoot.The insulin pump will be returned for analysis.
 
Manufacturer Narrative
The device was received with a constant blank flashing white light on the display followed by an unexpected intermittent beep alarm due to vertical cracked lcd controller.Unable to perform the self test, sleep current measurement, active current measurement, and the displacement test or verify missing segments/partial display due to display anomaly.The pump was received with cracked lcd glass, missing retainer and missing reservoir tube o-ring.A test reservoir was installed and did not lock in place due to missing retainer.
 
Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0955-2020.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.
 
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Brand Name
630G INSULIN PUMP MMT-1715KL 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
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
8185464805
MDR Report Key8280922
MDR Text Key134183268
Report Number3004209178-2019-48422
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00763000072520
UDI-Public(01)00763000072520(17)181102
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/02/2018
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Device Lot NumberHG2HEKV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2019
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/18/2019
Initial Date FDA Received01/28/2019
Supplement Dates Manufacturer Received04/17/2019
10/14/2019
Supplement Dates FDA Received04/19/2019
05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberZ-0955-2020
Patient Sequence Number1
Patient Age8 YR
Patient SexMale
Patient Weight27 KG
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