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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 Device Displays Incorrect Message (2591)
Patient Problems Fall (1848); Hypoglycemia (1912); Injury (2348); Loss of consciousness (2418)
Event Date 04/01/2017
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.

 
Event Description

Customer reported via phone call of receiving a motor error alarm and no delivery alarm. No delivery alarm was resolved with a complete set change. During troubleshooting for motor error alarm, it was found that insulin pump alarm history contains neither an e70 alarm nor more than one motor error alarm. Customer reported of having low blood glucose and passed out and broke her nose. Customer was taken to the emergency room on (b)(6) 2017 with blood glucose of 31 mg/dl. Customer was treated with iv and was wearing insulin pump at the time of hospitalization.

 
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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 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 Key6484176
MDR Text Key72499090
Report Number3004209178-2017-42106
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 04/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2017
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
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: 04/11/2017 Patient Sequence Number: 1
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