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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 Problem Inaccurate Delivery (2339)
Patient Problems Hyperglycemia (1905); Underdose (2542)
Event Date 01/11/2016
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
The customer's mother reported via phone call of issues with customer's high blood glucose levels.The customer's blood glucose level was reported to be 600mg/dl.The mother states there was an incident where the device delivered only 1 unit of insulin and shows having delivered 13 units on previous occasions.The mother states there were no alarms.The mother states they treated with the help of their healthcare provider.The mother states they adjusted the vassal rate and changed out the set.The mother refused to troubleshoot for the highs.The mother also states of incident where meter was reading 75mg/dl, and the sensor was reading 58mg/dl.The caller states there were no low alerts.The pump was not present at the time, so troubleshoot could not be conducted.The mother was advised to call back when pump is available, in order to troubleshoot.
 
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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 Key5403060
MDR Text Key37275473
Report Number3004209178-2016-84370
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 other
Type of Report Initial
Report Date 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 01/15/2016
Initial Date FDA Received02/01/2016
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) Other;
Patient Age9 YR
Patient Weight32
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