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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 Problems Incorrect Or Inadequate Test Results (2456); High Readings (2459)
Patient Problems Fatigue (1849); Hyperglycemia (1905)
Event Date 01/15/2017
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.
 
Event Description
A customer reported via phone call indicating that they were hospitalized on (b)(6) 2017 with a blood glucose level of 600 mg/dl due to pneumonia.The customer felt symptoms of vomiting fatigue, and dehydrated.The customer was treated for their blood glucose with their insulin pump.The customer was wearing the insulin pump during their hospital stay.The customer sated that they had a failed battery test.The customer returned the product for analysis.
 
Manufacturer Narrative
The insulin pump passed functional testing including displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test.The insulin pump was received with normal operating currents and no unexpected off no power alarm, low battery alarm or failed battery alarm noted.The insulin pump passed the displacement accuracy test.The insulin pump had cracked case at the display window corner, minor scratched lcd window, cracked battery tube threads and cracked reservoir tube lip.
 
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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 Key6297210
MDR Text Key66398298
Report Number3004209178-2017-88624
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 consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/15/2017
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-751NAS
Device Catalogue NumberMMT-751NAS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/30/2017
Initial Date FDA Received02/02/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/07/2017
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight73
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