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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-551NAS
Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Date 04/30/2015
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time. (b)(4).

 
Event Description

Customer reported via phone call that the insulin pump sensors are malfunctioning. The serter does not release the sensor after the 2nd button press and the needle hub is stuck in the serter mechanism. Customer's blood glucose level is 39 mg/dl. Customer advised they knew their blood glucose was low because they continually gave themselves insulin. Customer refused to troubleshoot for low blood glucose levels. Troubleshooting performed for hub being stuck in the serter. Customer was advised to return the sensor back and understood that a replacement would be sent out.

 
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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 MINIMED
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5106534
MDR Text Key26827495
Report Number2032227-2015-50144
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 09/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-551NAS
Device Catalogue NumberMMT-551NAS
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 Received09/09/2015
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: 09/26/2015 Patient Sequence Number: 1
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