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

Model Number	MMT-551LNAP
Medical Device Problem Codes	Obstruction of Flow (2423); Priming Problem (4040)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that they experienced high and low blood glucose level.Customer¿s blood glucose were 574 mg/dl to 36 mg/dl.The customer also reported other blood glucose values such as over 200 mg/dl.The customer was reported that the insulin squirted during priming.The customer reported that the insulin pump had unexplained no delivery alarms.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test.Device primed properly.No excessive no delivery or occlusion alarm noted.

• Brand Name: 530G INSULIN PUMP MMT-551LNAP
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 8585033
• Report Number: 3004209178-2019-93431
• Device Sequence Number: 2294020
• Product Code: OZO
• UDI-Device Identifier: 00643169933026
• UDI-Public: (01)00643169933026
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-551LNAP
• Device Catalogue Number: MMT-551LNAP
• Device Lot Number: A5551LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR