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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-551NAS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988); Loss of consciousness (2418)
Event Date 09/03/2015
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. (b)(4).

 
Event Description

The customer reported via phone call that she was hospitalized on (b)(6) 2015. Her blood glucose level at the time of admission was unknown. Her blood glucose level was 310 mg/dl before she went to bed. Around two in the morning her blood glucose level was 32 mg/dl. The customer was not wearing her glasses and she thought she saw her blood glucose level was 324 mg/dl. As a result she took 3 units of insulin to bring her blood glucose down and took another 3 units because she wanted to eat something. She did not end up eating anything and went back to sleep. Next thing she knows the her husband called the paramedics and they were at her home. The device was not returned.

 
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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 Key5098365
MDR Text Key26590914
Report Number2032227-2015-48084
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 CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-551NAS
Device Catalogue NumberMMT-551NAS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2015
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 Unkown

Patient TREATMENT DATA
Date Received: 09/23/2015 Patient Sequence Number: 1
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