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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 Circuit Failure (1089); Battery Problem (2885); Power Problem (3010); No Apparent Adverse Event (3189)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 08/04/2019
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. 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
It was reported that the insulin pump alarmed hardware low level failure. The customer¿s blood glucose level was unknown at the time of the incident. Customer was unable to clear the alarm. The device will be returned for analysis.
 
Manufacturer Narrative
Device passed displacement test, rewind, prime/seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement, and self test. Device properly connected to the guardian link 2 and green test plug. No communication anomaly noted. No battery or power anomalies noted during testing or in power graph. Pump error 63 alarm (variable 3) confirmed in the insulin pump history due to broken pin 6 trace (sda) and pin 1 trace (vdd) on keypad assembly.
 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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
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 Key8891648
MDR Text Key154459201
Report Number2032227-2019-46643
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,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/02/2018
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG2ABGC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2018
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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