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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-551NAH
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Date 03/17/2014
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. (b)(4).

 
Event Description

The customer reported via phone call that they experienced low blood glucose due to over bolus. The customer's blood glucose was 45 mg/dl at the time of incident. The customer stated that they treated the low blood glucose. The customer stated that the drive support cap appeared normal. The customer stated that the insulin pump was not exposed to high magnetic fields. The customer stated that the reservoir was showing the same amount of insulin as shown on the status screen. The insulin pump will not be 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 Key5653958
MDR Text Key45193510
Report Number3004209178-2016-46838
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 CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-551NAH
Device Catalogue NumberMMT-551NAH
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 Received03/17/2014
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: 05/13/2016 Patient Sequence Number: 1
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