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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Overdose (1988)
Event Date 07/01/2015
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. This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.

 
Event Description

It was reported that the customer passed away in a vehicle. The cause of death was overdose; lethal mix of heroin, thc, and alcohol. The caller stated that the customer was a diabetic as well as an addict. The caller did not know the customer's blood glucose at the time of passing. The caller stated that the customer never used the insulin pump. The caller agreed to return the insulin pump.

 
Manufacturer Narrative

The insulin pump passed functional test including prime, displacement, rewind, basic occlusion, occlusion and excessive no delivery alarm tests. The insulin pump had a cracked reservoir tube lip noted during visual inspection. Data analysis: unable to performed due to no history available on history download. No data was available due to insulin pump being received without battery in the battery tube.

 
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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 Key5086010
MDR Text Key26108749
Report Number2032227-2015-45950
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
Type of Report Initial,Followup
Report Date 09/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2015
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? Device Returned To Manufacturer
Date Returned to Manufacturer10/05/2015
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2015
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

Patient TREATMENT DATA
Date Received: 09/17/2015 Patient Sequence Number: 1
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