MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/25/2018
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.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 or Problem Description
The customer reported via phone call that they had high blood glucose.The customer¿s blood glucose level was unknown and current blood glucose was 375 mg/dl.The customer¿s blood glucose level was 400 mg/dl, 197 mg/dl, 140 mg/dl, 380 mg/dl, 110 mg/dl.The customer was treated with syringe.The customer had symptoms such as nausea.The customer does not allege pump was under delivering.The customer declined to continue troubleshooting for other possible causes of high blood glucose.The customer was advised to change entire set, reservoir and insulin and treat per health care professional instructions.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received with blank display due to corroded battery tube spring contact and corroded battery tube.Unable to perform all functional testing including the operating currents, unexpected restart error test, rewind, basic occlusion, occlusion, prime and excessive no delivery test due to blank display.The information provided in concomitant reporting section with the initial report was incorrect.The correct information has been included with this report.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 7684896
• Report Number: 2032227-2018-08195
• Device Sequence Number: 1315890
• Product Code: OYC
• UDI-Device Identifier: 00613994223708
• UDI-Public: (01)00613994223708(17)091231
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/27/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2009
• Device Model Number: MMT-522NAS
• Device Catalogue Number: MMT-522NAS
• Device Lot Number: A000093863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: 59 YR
• Patient Weight: 73