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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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

The customer reported via phone call that the customer visit to emergency room due to unknown reason, on unknown date. The customer blood glucose level was unknown. The customer was assisted with troubleshoot. Customer stated that the insulin pump was not giving the proper amount of insulin at times. Customer believe insulin pump had a small crack in the screen and goes through batteries rapidly. The devices will not be returned for analysis.

 
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Brand Name530G INSULIN PUMP MMT-751LNAL
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
8185464805
MDR Report Key8638937
MDR Text Key146036489
Report Number2032227-2019-06317
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751LNAL
Device Catalogue NumberMMT-751LNAL
Device LOT NumberA4751LNALJ
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/17/2016
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: 05/23/2019 Patient Sequence Number: 1
Treatment
FRN-RSVR, UNOMED INF SET
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