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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAB
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hypoglycemia (1912)
Event Date 11/04/2017
Event Type  Injury  
Manufacturer Narrative
The information provided that the date of event with the initial report was incorrect. The correct information has been included with this report.
 
Event Description
Event date has been changed to (b)(6) 2017.
 
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
The customer's spouse reported that the customer got hospitalized due to low blood glucose on november 4, 2017 with blood glucose of below 20 mg/dl at the time of the incident. The customer was at 111 mg/dl at the time of admission. The customer experienced symptoms such as loss of cognitive functions. The customer was wearing the insulin pump during the incident. The caller stated that the customer bolused too much and crashed. Troubleshooting was not completed as the customer was not present at the time of the call. The insulin pump will not be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751NAB
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 Key7035925
MDR Text Key113641125
Report Number2032227-2017-66160
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAB
Device Catalogue NumberMMT-751NAB
Device Lot NumberA4751NABJ
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/15/2017 Patient Sequence Number: 1
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