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

Model Number MMT-551NAP

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 they were hospitalized due to a low blood glucose on (b)(6) 2017 with a blood glucose level of 32 mg/dl.The customer was visiting her mother in the hospital and passed out.She was taken to the er portion of the hospital due to the low.The blood glucose value at the time of admission was 31 mg/dl.The customer was treated for the low blood glucose with two bags of d50.The customer was wearing the pump at the time of the hospitalization.The customers current blood glucose level was 353 mg/dl, which she treated with food.The technician performed troubleshooting and found the insulin pump had been worn during a mammogram.The customer requests the insulin pump be replaced due to possible over delivery.The customer the customer states that these lows have been going on for two weeks and experienced a low blood glucose of 50 mg/dl prior to the hospitalization.The insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin pump passed all functional testing, including the idle current measurement test, run current measurement test, self - test, off no power test, unexpected restart error test, displacement test, basic occlusion test, occlusion test, prime test, rewind test, excessive no delivery test and displacement accuracy test.The displacement test functioned properly.The motor passed motor test.The insulin pump was received with a slightly stained end cap sticker, cracked reservoir tube lip, cracked battery tube threads, cracked reservoir tube and minor scratched lcd window.

• Brand Name: 530G INSULIN PUMP MMT-551NAP
• 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: 6673385
• MDR Text Key: 78589097
• Report Number: 2032227-2017-24226
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404281
• UDI-Public: (01)00643169404281
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A3551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 142