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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-551NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAL
Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017); Moisture or Humidity Problem (2986); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5. 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 reported via phone call that the insulin pump display was blank. Customer blood glucose reading is 105 mg/dl. Troubleshoot was performed. Customer was not calling back after receiving a new battery cap. Customer insulin pump was making loud noise, battery was removed but the issue reoccurred. Customer stated there was no physical damage on the insulin pump. Customer stated the insulin pump was exposed to sweat. Customer was advised to remove the battery for 10 minutes and reinsert it. Customer was using (b)(6) battery; new battery was inserted but the display did not return. Customer was advised to discontinue use of the pump and revert to backup plan per healthcare provider instructions. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
The insulin pump was received with blank display and constant tone due to moisture damage on the electronics assembly. Unable to perform all functional testing including the operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to blank display. The insulin pump was received with moisture damage motor, vibrator, keypad and battery tube assembly. The insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked belt clip slot, stained end cap sticker and cracked battery tube threads.
 
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Brand Name530G INSULIN PUMP MMT-551NAL
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 Key6723004
MDR Text Key80509054
Report Number2032227-2017-29473
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169404274
UDI-Public(01)00643169404274
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 Patient
Type of Report Initial,Followup
Report Date 08/23/2017
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-551NAL
Device Catalogue NumberMMT-551NAL
Device Lot NumberA3551NALJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2017
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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