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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-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAS
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Seizures (2063); Shock, Insulin (2264); Coma (2417)
Event Date 07/10/2016
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¿s mother reported via phone call that they were hospitalized due to low blood glucose level on (b)(6) 2016. Customer¿s blood glucose level was 35 mg/dl. Customer had seizure when customer did not woke up due to low blood glucose level. Customer was treated in the emergency medical services for low blood glucose level. Customer did not alleged that the insulin pump was over delivering. Customer had brittle diabetic and that event caused low blood glucose level. Customer was unable to confirm that the drive support cap was damaged or not as the insulin pump was lost. Customer was declined to troubleshooting. The insulin pump will not be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-551NAS
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 Key9797272
MDR Text Key182293049
Report Number3004209178-2020-81907
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-551NAS
Device Catalogue NumberMMT-551NAS
Device Lot NumberA2551NASJ
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/08/2013
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: 03/06/2020 Patient Sequence Number: 1
Treatment
FRN-MMT-332A-RSVR, UNOMED SET
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