MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number	9500-27
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading.Bg and cgm values were not provided.No additional patient or event information was available.A root cause could not be determined.Multiple attempts were made by tandem technical support to follow-up with the customer on the reported issue, but no response was received.

• Brand Name: T:SLIM G4 SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 11517545
• Report Number: 3013756811-2021-32377
• Device Sequence Number: 19845360
• Product Code: OYC
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR