MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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.

• Brand Name: 530G INSULIN PUMP MMT-551NAH
• Type of Device: ARTIFICIAL 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 Key: 6846724
• MDR Text Key: 85129081
• Report Number: 2032227-2017-45087
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503632
• UDI-Public: (01)00643169503632
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAH
• Device Catalogue Number: MMT-551NAH
• Device Lot Number: A4551NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 145