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

Model Number	MMT-551RNAL
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	08/12/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported via phone call that they insulin pump was damaged and that they also experienced a low blood glucose level of 54 mg/dl after the damage was discovered.The customer that they were trying to tighten the battery cap when they heard a crack.The customer also mentioned that the insulin pump went into threshold suspend.The customer reported treating for a high blood glucose of 188 mg/dl and 273 mg/dl with the insulin pump bolus.The customer stated that their current blood glucose level during the call was 58 mg/dl after treating with glucose tabs and protein milk shake.Troubleshooting for damage was performed and the battery compartment was found damaged.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Findings: pump passed all functional testing including the displacement, operating currents, rewind, basic occlusion, occlusion, prime and excessive no delivery test.Pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, cracked case reservoir tube window corner and cracked battery tube threads.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• Brand Name: 530G INSULIN PUMP MMT-551RNAL PRDGM CLEAR RECERT
• 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: 6837739
• Report Number: 2032227-2017-43712
• Device Sequence Number: 636876
• Product Code: OZO
• UDI-Device Identifier: 00643169507937
• UDI-Public: (01)00643169507937
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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-551RNAL
• Device Catalogue Number: MMT-551RNAL
• Device Lot Number: A3551RNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 08/12/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Weight: 164