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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)
Event Date 11/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The unit did not have a battery installed when received. Unit passed 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 test and the dat test at 0. 0873 inches. Unit uploaded properly using carelink. Unit had scratched case, pillowing keypad overlay and cracked retainer. The test p-cap and reservoir does lock in place in the reservoir compartment. Data analysis: (b)(6) 2020 daily total of all insulin delivered
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43. 1. (b)(6) 2020 daily total of all insulin delivered
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41. 7. (b)(6) 2020 daily total of all insulin delivered
=
41. 2. (b)(6) 2020 daily total of all insulin delivered
=
47. 3. (b)(6) 2020 daily total of all insulin delivered
=
18. 275. (b)(6) 2020 daily total of all insulin delivered
=
0. (b)(6) 2020 daily total of all insulin delivered
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0. There was no data listed after (b)(6) 2020.
 
Event Description
It was reported via phone call by customer's wife that the customer passed away. It was also stated that the customer had renal failure, cholesterol and vascular issues. The cause of the death was found to be congested and diastolic heart failure. No further information was given due to data protection. The caller returned the insulin pump for analysis. The case is reported only on the basis of failure analysis.
 
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Brand Name630G INSULIN PUMP MMT-1715KL 630G
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key12487870
MDR Text Key273094503
Report Number2032227-2021-194624
Device Sequence Number1
Product Code OZO
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
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Device Lot NumberHG4E2FC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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