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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-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAS
Device Problem Priming Problem (4040)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sw 3. 0d on the event date (b)(6) 2021. Customer returned pump for an alleged pump prime/fill anomaly. Pump passed a21 error test, seat, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test. Pump history download using thds was successful. A47 alarms found on the history file which caused corrupted data. Unable to confirm the reported event date due to the corrupted data. A47 alarms are due to the pump not having power for a long period of time. Test reservoir lock properly inside the reservoir tube. The following were noted during visual inspection: no cosmetic damage found. Not confirmed prime/fill anomaly during testing. Unit passed required testing.
 
Event Description
Information received by medtronic indicated that the insulin pump was continue to came out during priming. Customer stated that insulin squirting out during the fill tubing process. No harm requiring medical intervention was reported. The customer will discontinue use of the device.
 
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Brand Name530G INSULIN PUMP MMT-751LNAS
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 Key13730452
MDR Text Key289965440
Report Number2032227-2022-127857
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 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751LNAS
Device Catalogue NumberMMT-751LNAS
Device Lot NumberA6751LNASJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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