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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 No Display/Image (1183)
Patient Problem Fall (1848)
Event Date 03/25/2017
Event Type  malfunction  
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that the insulin pump's display was blank, then stated that there was a partial display. Customer confirmed that the device was recently worn during a fall. Blood glucose level at the time of the incident was 123 mg/dl. During troubleshooting, the customer was unable to get the display to return. The customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.
 
Manufacturer Narrative
The pump was received with a cracked and bleeding lcd glass. Unable to verify the blank display anomaly due to the cracked and bleeding lcd glass. The pump had minor scratches on the lcd window, a cracked case near the display window corners, cracked battery tube threads, a cracked reservoir tube lip and a cracked lcd window. Unable to perform the functional tests due to the display anomaly.
 
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Brand Name530G INSULIN PUMP
Type of DeviceOZO
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 Key6520136
MDR Text Key73735973
Report Number3004209178-2017-47877
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
PMA/PMN Number
120010
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 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
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

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