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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-751NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAL
Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)
Patient Problem Hyperglycemia (1905)
Event Date 10/25/2017
Event Type  Injury  
Manufacturer Narrative
Pump received with unresponsive buttons due to moisture damage at keypad traces. No button error alarm noted. Traces of corrosion found at the electronic assembly and motor assembly per visual inspection. Unable to perform functional testing including the displacement, operating currents, unexpected alarm error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to unresponsive buttons. Pump received with minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, missing end cap sticker, stained address/serial number label and cracked reservoir tube lip.
 
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
The customer reported via phone call the insulin pump alarmed button error and a high blood glucose event. The customer¿s blood glucose was 522 mg/dl at the time of incident. Customer stated that the insulin pump alarmed button error after battery was changed. Customer also reported that the insulin pump was exposed to moisture that could have led to button error. Button error troubleshooting was performed and unable to confirm if the time is advancing due to button error alarm. Customer also reported to have experienced a high blood glucose of 522 mg/dl and unable to treat due to backup plan was not available. No high blood glucose troubleshooting was performed. The customer was advised to discontinue use of pump and revert to back-up plan. The insulin pump is being replaced and is expected to return for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751NAL
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 Key6994202
MDR Text Key105635799
Report Number2032227-2017-63295
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 Patient
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAL
Device Catalogue NumberMMT-751NAL
Device Lot NumberA4751NALJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
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

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
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