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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-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Priming Problem (4040)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2022
Event Type  malfunction  
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
Information received by medtronic indicated that the insulin pump was rejecting new batteries and and customer had to change the batteries in less than 7 days.Customer reported that the insulin pump was making grinding noise and was louder during rewind.Insulin pump also had no delivery alerts.No harm requiring medical intervention was reported.The device is not expected to be returned for analysis.
 
Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Retainer ring = black.On 03/04/2022, the customer alleged no delivery/occlusion alarms, back light anomaly, charge/battery lasts less than expected, failed battery test alarm, prime/fill anomaly, and rewind anomaly.No backlight anomaly was noted during testing.Pump passed the self-test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, sleep current measurement, active current measurement, and occlusion test.No unexpected insulin flow blocked, failed battery test, prime/fill anomaly, nor rewind anomaly alarms noted during testing.Pump successfully downloaded to thus.No confirmed no delivery, failed battery test, prime/fill anomaly, nor rewind anomaly alarms in the pump downloaded history.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range.In further full review in the pump history, no battery related alarms were found on the event date of 03/04/2022.The electronic assemblies and motor assemblies were inspected, and no anomalies noted.Force sensor zero offset within specification (22.5mv).Motor was taken to the test bench where it rewound with no errors or alarms noted.The following were noted during visual inspection: cracked case above arrow and battery icon and pillowing keypad overlay.In summary, pump passed required testing.Customer alleged for no delivery/occlusion was not confirmed.Customer alleged for rewind anomaly was not confirmed.Customer alleged for prime/fill anomaly was not confirmed.Customer alleged for charge/battery lasts less than expected was not confirmed.Customer alleged for failed battery test alarm was not confirmed.Customer alleged for backlight anomaly was not confirmed.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.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-1715K 630G BLACK MG
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 Key13691650
MDR Text Key289895088
Report Number2032227-2022-121579
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000316631
UDI-Public(01)000000763000316631
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 09/14/2022
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-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG47VYP
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/04/2022
Initial Date FDA Received03/08/2022
Supplement Dates Manufacturer Received09/06/2022
Supplement Dates FDA Received09/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age65 YR
Patient SexFemale
Patient Weight95 KG
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