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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-751NAP
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Date 01/09/2017
Event Type  Injury  
Manufacturer Narrative

Unit functioned properly during functional check including rewind and basic occlusion, occlusion, prime/compromised force sensor system, excessive no delivery, displacement, self-test, unexpected restart test, and all operating current measurement were normal. No unexpected low battery, weak battery, battery out off limit, or off no power alarm noted. Insulin pump was received with minor scratched display window, cracked case at display window corners, and cracked reservoir tube lip.

 
Event Description

The customer reported via phone call that the insulin pump alarmed weak battery and battery out limit. Customer's blood glucose level dropped to 46 mg/dl. He treated his blood glucose level with orange juice. He did not eat enough the night before and gave himself too much insulin. The insulin pump was working fine. The insulin pump alarmed battery out limit again after troubleshooting. Customer was advised to discontinue use of the device and revert to backup plan. The customer was advised that the device would be replaced and agreed to return the product for analysis.

 
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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 Key6362836
MDR Text Key68465710
Report Number3004209178-2017-92576
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 01/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAP
Device Catalogue NumberMMT-751NAP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
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: 02/27/2017 Patient Sequence Number: 1
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