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

Model Number MMT-1715K

Device Problem Mechanical Problem (1384)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/10/2020

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.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 of being hospitalized due to epileptic seizure on unknown date.The customer reported that the seizure was not due to blood glucose or insulin pump but due to the customer being epileptic.The customer went into cardiac arrest while being hospitalized.The insulin pump was removed for five weeks while the customer was hospitalized.The customer attempted to reconnect to the insulin pump after five weeks and received a pump error alarm.The insulin pump will be returned for analysis.

Manufacturer Narrative

Insulin pump error 35 alarm noted in device history and critical pump error due to out of specification force sensor zero offset.Unable to perform the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement accuracy test and displacement test due to critical pump error.Device received with missing display window cover, pillowing keypad overlay, cracked case corner of the belt clip rails near the battery compartment and cracked battery tube threads.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.

Manufacturer Narrative

On(b)(6) 2020 the customer alleged pump critical error (open book) and pump error 35 alarm.Device received with no allegation for diabetes related.However, hospitalized for seizure and cardiac arrest.The test p-cap locks properly in place in the reservoir compartment noted.Device received with missing display window cover, pillowing keypad overlay, cracked case corner of the belt clip rails near the battery compartment and cracked battery tube threads.Pump was received with a critical pump error (open book image) alarm.Unable to perform the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement test, active current measurement test, displacement accuracy test and self test due to critical pump error (open book image) alarm.Successfully downloaded history files and traces using thump.Device was cut open to perform visual inspection and found no moisture damage on the electronic assembly, force sensor and motor assembly.Force sensor zero offset out of spec range (-0.4mv).Critical pump error (open book image) alarm was triggered by a pump error 35 fatal alarm confirmed in the history file or traces on (b)(6) 2020 at 2:03:43 pm.Unable to perform the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement accuracy test and displacement test due to critical pump error (open book).In summary, critical pump error (open book image) alarm confirmed due to pump error 35 alarm.Pump error 35 alarm confirmed due to force sensor out of spec range.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.

• 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 10710612
• MDR Text Key: 212286240
• Report Number: 2032227-2020-194213
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169656840
• UDI-Public: (01)000000643169656840(17)180424
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2018
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG233ML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-UNK-RSVR, UNOMED INF SET; FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 156 KG