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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-551NAL
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Fever (1858); Hyperglycemia (1905); Hypoglycemia (1912); Pneumonia (2011); Brain Injury (2219)
Event Date 07/08/2016
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.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.Please see medwatch report 3004209178-2016-60370.
 
Event Description
It was reported that the customer was hospitalized on (b)(6) 2016.The customer had an issue with the insulin pump on (b)(6) 2016 and disconnected from the device.The caller stated that prior to disconnecting from the device, the customer was struggling with high and low blood glucose.On 06/20/2016 the customer reported the device issue.On (b)(6) 2016, the customer experienced low blood glucose, was unresponsive, was hospitalized, and was placed on a feeding tube.The customer passed away on (b)(6) 2016, in a hospital.The customer had a brain injury and pneumonia.The caller stated that upon admission to the hospital on (b)(6) 2016, the customer had fever.The caller did not know the customer's blood glucose at the time of death.The customer was not wearing the insulin pump at the time of death; it had been discounted eighteen days prior to passing.The customer disconnected the insulin pump and was treating with manual injections.The pump will return for analysis.
 
Manufacturer Narrative
It was reported by the deceased customer's sister (b)(6) they never received an official cause of death but did mention that the customer was in a coma at the time of their passing.
 
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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 Key5865669
MDR Text Key51762248
Report Number3004209178-2016-63617
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 08/12/2016
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-551NAL
Device Catalogue NumberMMT-551NAL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/29/2016
Initial Date FDA Received08/10/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/17/2016
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) Hospitalization;
Patient Age38 YR
Patient Weight76
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