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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 Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Unable to perform the displacement test and the p-cap/reservoir will not lock properly due to missing retainer.Device received with missing reservoir tube o-ring, broken reservoir tube lip and fading serial number label.The power management tool confirmed power error detected, low battery alert, power loss alarm, triggered when the backup battery loaded voltage (loaded vlith) was less than 3.5v for 4 consecutive hours due to connector resistance pcb 1.After disconnecting and reconnecting the internal battery connector on pcb 1, the pump was monitored and functioned properly.
 
Event Description
It was reported via phone call that the insulin pump had a recurring replace battery now alarm with less than 8 hours from getting a low battery alert.Blood glucose level at the time of the incident was 8.7 mmol/l.Troubleshooting was completed.The customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.
 
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
PUMP MMT-1714K 630G BLACK MMOL CANADA
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 Key9352608
MDR Text Key174765674
Report Number2032227-2019-120636
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169782396
UDI-Public(01)00643169782396
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/22/2022
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 Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG22UNB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received11/21/2019
Supplement Dates Manufacturer Received10/14/2019
Supplement Dates FDA Received05/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2017
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
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