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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Cardiac Arrest (1762); Emotional Changes (1831); Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988); Cramp(s) (2193); Dizziness (2194); Anxiety (2328)
Event Date 12/21/2015
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
 
Event Description
The customer reported via phone call that he was hospitalized on (b)(6) 2015 due to a high blood glucose level of 900 mg/dl.The customer had cramps, felt anxiety, was grouchy, and dizzy.The customer had a heart attack that day.He treated his blood glucose level with insulin drip.The customer was wearing the insulin pump at the time of hospitalization.In the hospital his blood glucose level dropped to 28 mg/dl due to a treatment therapy in the hospital.The hospital staff miscalculated the dosage.The device was not returned.
 
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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 Key5958265
MDR Text Key54994500
Report Number3004209178-2016-79508
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
Report Date 08/26/2016
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-751NAB
Device Catalogue NumberMMT-751NAB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/26/2016
Initial Date FDA Received09/16/2016
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 Age51 YR
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