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

Model Number MMT-551LNAH

Device Problems False Reading From Device Non-Compliance (1228); Insufficient Flow or Under Infusion (2182)

Patient Problem Hyperglycemia (1905)

Event Date 12/10/2017

Event Type  Injury  

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 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 that the customer had high blood glucose level.The customer¿s blood glucose level was 300 mg/dl at the time of incident and current blood glucose level was 57 mg/dl.The customer was treated with manual injection for high blood glucose level.The customer¿s blood glucose level was around 300 mg/dl and 500 mg/dl, in the morning it was 599 mg/dl and went down to 96 mg/dl after injecting manual injection.The customer reported that she did not have any symptom related to high blood glucose level however, had stomach virus.The customer reported that the insulin pump was under delivering as the blood glucose level was not going down even after bolusing multiple times.The drive support cap was normal.The customer removed reservoir, rewound, reinserted reservoir and ran manual prime and filled tubing with current set and insulin exited.Customer was advised to discontinue use of the device and revert to a back-up plan.The customer was advised that the device would be replaced and agreed to return the insulin pump for analysis.

Manufacturer Narrative

Device received with intermittent button response due to flattened (escape and act ) button dome switch (no crease) and partial unlocked lcd keypad connector noted during visual inspect.Unable to perform all functional testing including the displacement, operating currents, unexpected restart error test , rewind, basic occlusion, occlusion, prime or compromised force sensor system alarm and excessive no delivery test or verify under delivery anomaly due to buttons not responding.Device received with cracked battery tube threads, cracked lcd window, minor scratched lcd window, cracked reservoir tube lip, cracked case display window corner, cracked belt clip slot and cracked case reservoir tube window corner.

• Brand Name: 530G INSULIN PUMP MMT-551LNAH
• 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: 7151736
• MDR Text Key: 95950126
• Report Number: 2032227-2017-77813
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507708
• UDI-Public: (01)00643169507708
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAH
• Device Catalogue Number: MMT-551LNAH
• Device Lot Number: A4551LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 06/11/2018
• 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 Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 84