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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-751NAP
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 12/18/2014
Event Type  Death  
Event Description

It was reported that the customer passed away at home, in her sleep. At this time the cause of death is unknown. The caller stated that an autopsy is being performed and it will be a while before he finds out the official cause of death and receives the death certificate. The caller stated that the customer had multiple surgeries because of a staph infection in her foot. The issue began in (b)(6) 2014. The customer's blood glucose at the time of death was unknown. The customer was wearing the insulin pump at the time of death. She was not using sensors and was not wearing one at the time of death. The caller stated that insulin pump was still at the funeral home. No further information is available at this time.

 
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.

 
Manufacturer Narrative

A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing. After testing, it was concluded that the device operated within specifications.

 
Manufacturer Narrative

The insulin pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test. The device had a cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked lcd window and cracked belt clip slot. Data analysis customer daily insulin total average from 61. 2 to 108. 95u, total basal insulin from 36. 75 to 61. 2 and total bolus insulin 0 to 67. 0u. The insulin pump passed the delivery volume accuracy test.

 
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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
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key4410701
MDR Text Key5280087
Report Number3004209178-2015-82915
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 Other,OTHER
Type of Report Initial,Followup,Followup
Report Date 05/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAP
Device Catalogue NumberMMT-751NAP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/20/2015
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2015
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

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