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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-751LNAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAH
Device Problems Improper or Incorrect Procedure or Method (2017); Failure of Device to Self-Test (2937); Pressure Problem (3012)
Patient Problems Bradycardia (1751); Hyperglycemia (1905); Nausea (1970); Vomiting (2144)
Event Date 08/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing. After testing, it was concluded that the device operated within specifications.
 
Event Description
It was reported via phone call that the customer experienced high blood glucose level of 327 mg/dl. The customer¿s blood glucose level was 207 mg/dl at the time of the incident. The customer¿s symptoms were nausea, vomiting, and shortness of breath. The customer was being treated at the hospital with manual injections, and was not wearing the insulin pump. Customer changed the infusion set on her own, which caused her blood glucose to rise and lead to her hospitalization. During troubleshooting, the insulin pump failed the high-pressure test. Customer was advised a replacement infusion set would be sent out. The insulin pump will be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751LNAH
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 Key6832254
MDR Text Key84067921
Report Number2032227-2017-42673
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 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751LNAH
Device Catalogue NumberMMT-751LNAH
Device Lot NumberA4751LNAHJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2017
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: 08/30/2017 Patient Sequence Number: 1
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