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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-751NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAH
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Hyperglycemia (1905); Pain (1994); Tachycardia (2095); Diabetic Ketoacidosis (2364)
Event Date 05/26/2017
Event Type  Injury  
Event Description
The customer reported via phone call that they were hospitalized for high blood glucose and diabetic ketoacidosis on (b)(6) 2017. Blood glucose reading was 460 mg/dl and over 465 mg/dl. The customer reported that insulin pump was under delivering. Customer had symptoms like tachycardia, extreme muscle pain, anxiety, low calcium, urine was positive for ketones. The customer was treated with insulin drip at the hospital. The insulin pump will not be returned for analysis.
 
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.
 
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Brand Name530G INSULIN PUMP MMT-751NAH
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
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key13313054
MDR Text Key284168599
Report Number2032227-2022-105022
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 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAH
Device Catalogue NumberMMT-751NAH
Device Lot NumberA4751NAHJ
Was Device Available for Evaluation? No
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/20/2015
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: 01/21/2022 Patient Sequence Number: 1
Treatment
FRN UNK RSR, UNO INF SET.
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