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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-551NAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAB
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hypoglycemia (1912); Pain (1994); Scarring (2061); Shock, Insulin (2264)
Event Date 09/10/2018
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 they were hospitalized on (b)(6) 2017 for a blood glucose of 40 mg/dl.The customer believed that the infusion set caused an over-delivery.Customer has been using insulin pump system within 48 hours of the hospitalization.The patient treated with glucagon and food.Additionally, the customer's blood glucose dropped to less than 13 mg/dl.The blood glucose was 51 mg/dl at the time of the incident and current blood glucose was 315 mg/dl and other blood glucose values were 354 mg/dl.The customer stated that, 31 years ago she was at 13 mg/dl blood glucose, while she pregnant at time the customer had suffered from a convulsion, fell, and hit their head.The customer received a scar on her eyebrow and was gushing blood.Troubleshooting was not completed for the low blood glucose.The insulin pump was not returned for analysis.
 
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Brand Name
530G INSULIN PUMP MMT-551NAB
Type of Device
ARTIFICIAL 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 Key7908854
MDR Text Key121698859
Report Number2032227-2018-33422
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169503625
UDI-Public(01)00643169503625
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 Other
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-551NAB
Device Catalogue NumberMMT-551NAB
Device Lot NumberA4551NABJ
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/11/2018
Initial Date FDA Received09/26/2018
Date Device Manufactured01/27/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
FRN RESERVOIRUNOMEDICAL INF. SET
Patient Outcome(s) Hospitalization;
Patient Age59 YR
Patient Weight181
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