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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-751NAS
Device Problems Low Test Results (2458); Charging Problem (2892)
Patient Problems Hypoglycemia (1912); Virus (2136)
Event Date 06/05/2016
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
A customer reported via phone call indicating that they were hospitalized on (b)(6) 2016 with a blood glucose level of 24 mg/dl.The customer was treated for their blood glucose with food and glucagon.The caller stated that the customer's low blood glucose levels were caused by being sick form the flu.The caller mentioned that they had issues with their charger for their transmitter and sensor.The customer used a second charger that they owned and the issue was resolved.The customer did not return the product back for analysis.
 
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Brand Name
530G INSULIN PUMP
Type of Device
OZO
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 Key5709205
MDR Text Key46898813
Report Number3004209178-2016-52664
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
PMA/PMN Number
120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/05/2016
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age26 YR
Patient Weight78
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