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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-551NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAH
Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Currently it is unknown whether or not the device may have caused or contributed to the event 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 motor error and a partial display issue. The customer¿s blood glucose level was 89 mg/dl at the time of the incident. The customer stated that the insulin pump alarmed motor error after it has been exposed to moisture. The customer stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields and was able to complete the rewind process. Customer also reported that the insulin pump screen had lines through it and it is fading. The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan. The insulin pump is being replaced and is expected to return for analysis.
 
Manufacturer Narrative
Unit power up properly after battery installation. No blank display, missing segment/partial display or fading noted. However, unit alarmed motor error during rewind due to moisture damaged the motor home switch. Also moisture damage electronic assembly and vibrator motor during visual inspection. Unable to perform operating current test, error test or all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to motor error alarms. Unit had minor scratched lcd window, cracked lcd window, cracked case at display window corners, cracked battery tube threads, cracked reservoir tube lip, broken belt clip slot, cracked reservoir tube window, cracked case at reservoir tube window corner and stained address/serial number label.
 
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Brand Name530G INSULIN PUMP MMT-551NAH
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 Key6846724
MDR Text Key85129081
Report Number2032227-2017-45087
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 01/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-551NAH
Device Catalogue NumberMMT-551NAH
Device Lot NumberA4551NAHJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
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

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