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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-751NAB
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Fall (1848); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Polydipsia (2604)
Event Date 12/26/2016
Event Type  Death  
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. A request to return the device has been made and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
It was reported that the customer passed away at home. The cause of death was complications from diabetes, hypertension, hyperlipidemia, copd. The caller stated that the night prior to passing, the customer was not feeling well, had a back ache and was thirsty. In the morning of passing, the customer was thirstier but did not want paramedics to be called, drank a few sips of juice and his head dropped; he passed away. The customer had sinus infection, fell on an iron pipe, went to a doctor, and fell three more times after that - prior to passing. The customer was put on muscle relaxers. The caller stated that they were unsure, but, the morning of passing, the customer's blood glucose was either 306 mg/dl or 316 mg/dl. The customer was wearing the insulin pump at the time of death. The customer was not using sensors. The caller agreed returning the insulin pump for analysis.
 
Manufacturer Narrative
The insulin pump was returned without a battery installed. The insulin pump passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement accuracy test. The insulin pump had cracked reservoir tube lip. Data analysis: there is no data available due to the insulin pump did not have a battery installed when received.
 
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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 Key6514346
MDR Text Key73448027
Report Number3004209178-2017-46325
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,Followup
Report Date 05/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAB
Device Catalogue NumberMMT-751NAB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? Yes
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: 04/22/2017 Patient Sequence Number: 1
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