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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-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAS
Device Problems Mechanical Problem (1384); Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problems Fatigue (1849); Hyperglycemia (1905)
Event Date 07/19/2020
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. 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¿s mother reported via phone call that they were experiencing high blood glucose. Blood glucose level at the time of the incident was 571 mg/dl and current was 312 mg/dl. Customer stated that she received motor error and the insulin pump kept asking for rewind as she got motor error 3 times during the bolus delivery. Customer stated that she took 7 units of a manual injection. Customer stated that was feeling sleepy and had dry mouth. Customer stated that stated the serial number sticker came off her insulin pump. Customer was able to clear alarm and insulin pump rewind. The insulin pump will be returned for analysis.

 
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Brand Name530G INSULIN PUMP MMT-751NAS
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
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
8185464805
MDR Report Key10324971
MDR Text Key200383595
Report Number2032227-2020-152662
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 07/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Device LOT NumberA4751NASJ
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/06/2014
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: 07/27/2020 Patient Sequence Number: 1
Treatment
FRN-MMT UNK-RSVR, UNOMED SET
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