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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-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAB
Device Problems Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 04/27/2020
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
Customer reported via phone call that they were hospitalized on (b)(6) 2020 as a result of hypoglycemia. Customer¿s blood glucose level at the time of incident was 53 mg/dl and 82 mg/dl at the time of hospitalization. Customer had been using insulin pump system within 48 hours of reported low blood glucose event. Customer had been experiencing low blood glucose for about 3 weeks since (b)(6) 2020. Customer stated that while in ambulance they were treated with intravenous sugar and in hospital was treated with glucose tablets and food. Customer stated that insulin pump was over delivering. Customer stated they are unable to describe any possible damage to the drive support cap. The reservoir will not be returned for analysis while the insulin pump will be returned for analysis.
 
Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0. 08750 inches. No over delivery anomaly or under delivery anomaly noted. The stop current and run current measurement tests are within specification. Device also passed self test, off no power alarm test and a21 error test. Device uploaded properly using care link. Drive support disk was inspected and no anomaly was noted. Device had cracked case at display window corner, scratched reservoir tube window, cracked reservoir tube lip and a missing end cap sticker. The test p-cap and reservoir does lock in place in the reservoir compartment. (b)(4).
 
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Brand Name530G INSULIN PUMP MMT-751NAB
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 Key10031729
MDR Text Key190109506
Report Number2032227-2020-114500
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,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAB
Device Catalogue NumberMMT-751NAB
Device Lot NumberA2751NABJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
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: 05/07/2020 Patient Sequence Number: 1
Treatment
UNOMED INFSET
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