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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 Device Operates Differently Than Expected (2913); Programming Issue (3014); Timer (3136)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Head Injury (1879); Hypoglycemia (1912); Injury (2348); Loss of consciousness (2418)
Event Date 05/15/2017
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 several low blood glucose levels and has fallen, hurt themselves, and lost consciousness. The customer stated that they had a broken thumb, big knot on the head, sprained shoulder and rotator cuff, and broken toes. The customer was assisted with low blood glucose troubleshooting. The customer's blood glucose level was 55mg/dl at the time of the incident and 123mg/dl during the call. The customer was treated for the low blood glucose with glucagon shots. The customer stated that they went to the hospital for the injuries acquired due to low readings. The insulin pump's programming was inaccurate and the customer was assisted with correcting the time. The customer also stated that the reservoir was showing the same amount of insulin as shown on the status screen and that there was lifestyle changes. The customer was advised to contact healthcare professional to discuss possible cause of low blood glucose and to monitor insulin pump. The customer stated that they were going to the hospital. The customer went on (b)(6) 2017 at 10:45 p. M. With a blood glucose of 233mg/dl and was wearing the insulin pump. 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 Key6660008
MDR Text Key78176496
Report Number2032227-2017-22707
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 06/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2017
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
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 Received05/27/2017
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/22/2017 Patient Sequence Number: 1
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