MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE METER

Model Number	7189
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.
Event or Problem Description
An advocate reported that the customer obtained blood glucose readings of 392 mg/dl and 60 mg/dl at 11:36 a.M.And 11:42 a.M.Respectively when using the contour meter.At 12:11 p.M., another testing was performed and a reading of 23 mg/dl was obtained.The customer was presenting symptoms such as headache and nausea.Based on the reading of 23 mg/dl and customer's symptoms, the school nurse gave juice to the customer.The customer also ate peanut butter.However, the symptoms persisted.The school nurse performed a test with her meter and obtained a reading of 590 mg/dl.No further event details were provided.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter and test strips were sent to the customer.The customer stated that the product details from the bottle of test strips were worn off and therefore, was unable to provide the information.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The customer did not return the suspected device for evaluation.Therefore, an in-house contour meter was tested with the in-house contour test strips using a blood sample, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 9756847
• Report Number: 1810909-2020-00104
• Device Sequence Number: 16766133
• Product Code: NBW
• UDI-Device Identifier: 00301937189012
• UDI-Public: 00301937189012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: Lay User/Patient
• Device Model Number: 7189
• Device Catalogue Number: 7189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR