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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-751NAL
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Hypoglycemia (1912); Overdose (1988); Loss of consciousness (2418)
Event Date 08/09/2015
Event Type  Injury  
Manufacturer Narrative

The unit passed the functional test including the displacement test, the rewind test, the basic occlusion test, the occlusion test, the prime test, and the excessive no delivery alarm test. There was no unexpected bolus delivery during testing. The unit functioned properly. The unit had a cracked reservoir tube lip. (b)(4).

 
Event Description

The customer called in to report an delivery anomaly. The customer gave himself a bolus at dinner, and then an hour later the insulin pump gave another "mystery" bolus that he did not remember programming. That caused the customer's blood glucose to fall to 11 mg/dl. The customer reported passing out and paramedics were called to the house. The customer refused hospitalization. The customer was treated at the house. The customer was informed to return the product for analysis, and was given a replacement device.

 
Manufacturer Narrative

The pump passed the delivery accuracy test.

 
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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 Key5047617
MDR Text Key24761974
Report Number2032227-2015-37852
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,Followup
Report Date 02/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAL
Device Catalogue NumberMMT-751NAL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2017
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 Unkown

Patient TREATMENT DATA
Date Received: 09/01/2015 Patient Sequence Number: 1
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