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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP OZO Back to Search Results
Model Number MMT-751NAL
Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)
Event Date 03/01/2016
Event Type  Injury  
Manufacturer Narrative

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

It was reported that the insulin pump alarmed for a motor error 3 - 4 times. The blood glucose reading was 130 mg/dl. The drive support cap appeared normal and recessed and the insulin pump had not been exposed to a strong magnetic field. The insulin pump passed the displacement test. It was also reported that the insulin pump did not suspend when the user had a low blood glucose, causing a low blood glucose of 24 mg/dl. The user was treated with juice. The user will discontinue use of the insulin pump and to revert to a back up plan per a health care professional's instructions. The insulin pump will be replaced and returned for analysis.

 
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Brand Name530G INSULIN PUMP
Type of DeviceOZO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5492930
MDR Text Key40118020
Report Number3004209178-2016-92508
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN Number120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAL
Device Catalogue NumberMMT-751NAL
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 Received03/03/2016
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: 03/10/2016 Patient Sequence Number: 1
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