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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-551NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAP
Device Problems Image Display Error/Artifact (1304); Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Currently, it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. Further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer parent reported via phone call that the insulin pump display was missing segments. Customer cannot recall blood glucose at the time of incident. Troubleshooting was performed. Customer smashed the insulin pump to a door. Customer stated there is an ink blot under the screen. Customer was advised to turn back to their back up plan and contact their healthcare provider if is needed. Customer agreed to replace the pump. The insulin pump will be returning for analysis.
 
Manufacturer Narrative
Findings: pump had missing segments/partial display due to severely cracked and bleeding lcd glass. Unable to perform the operating currents measurement, self test, unexpected restart alarm error test, displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to lcd anomaly. Pump had cracked case at display window corner, battery tube threads, reservoir tube, reservoir tube lip, minor scratched display window and missing end cap sticker.
 
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Brand Name530G INSULIN PUMP MMT-551NAP
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
MDR Report Key6721236
MDR Text Key80415560
Report Number2032227-2017-29271
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169404281
UDI-Public(01)00643169404281
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551NAP
Device Catalogue NumberMMT-551NAP
Device Lot NumberA3551NAPJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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