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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 Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)
Event Date 01/21/2017
Event Type  Injury  
Manufacturer Narrative

Insulin pump passed all functional testing including the displacement, operating currents, rewind, basic occlusion, occlusion, prime/compromised force sensor system, and excessive no delivery test. No excessive no delivery alarm noted during test. Insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, and cracked battery tube threads.

 
Event Description

The customer reported via phone call that she had the insulin pump off for an hour and a half and her blood glucose level went from being over 600 mg/dl to 63 mg/dl. The customer was receiving no delivery alarms during regular basal. The customer treated her blood glucose level with the insulin pump. The bolus estimate was too high. The customer insisted the insulin pump gave her too much insulin. 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 Key6422854
MDR Text Key70518840
Report Number3004209178-2017-97126
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 01/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2017
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? Device Returned To Manufacturer
Date Returned to Manufacturer02/02/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2017
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: 03/21/2017 Patient Sequence Number: 1
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