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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 Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)
Patient Problems Hypoglycemia (1912); Overdose (1988); Confusion/ Disorientation (2553)
Event Date 05/26/2017
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.

 
Event Description

Customer reported via phone call that they experienced low blood glucose levels of 34mg/dl. The customer was assisted with troubleshooting. The customer was treated for the low blood glucose with juice. Customer¿s blood glucose level was 78mg/dl at the time of the call. The customer declined troubleshooting for low blood glucose. The customer stated that they were low due to treating for high blood glucose that was reported previously. The customer seemed confused during the call. The customer stated their blood glucose was 38mg/dl during the call but a new test stated it was 91mg/dl and eventually 78mg/dl. The customer was not connected to the insulin pump while priming the device. There was no indication that the insulin pump over delivered insulin. The product will not be returned for analysis.

 
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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
MDR Report Key6656973
MDR Text Key78066103
Report Number2032227-2017-22312
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 PATIENT
Type of Report Initial
Report Date 06/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device LOT NumberHG1SG9L
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/11/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/21/2017 Patient Sequence Number: 1
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