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

Model Number	7080G
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.The customer's age and weight were not provided.
Event or Problem Description
The customer reported that she obtained a blood glucose reading of 250 mg/dl on the contour meter.The customer became unconscious.The paramedic was called and the customer was taken to an emergency room.The customer stated that a test was performed in the hospital with their meter and a reading of 23 mg/dl was obtained.The customer stated that both readings were taken 10 minutes apart.The customer did not remember if she received any treatment.No further event details were provided.The customer was advised to return the test strips for evaluation.A replacement meter kit was sent to the customer.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 product for evaluation.Therefore, an in-house testing was performed using the in-house contour meter with in-house contour test strips, which gave satisfactory performance.Additionally, a device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.
Additional Manufacturer Narrative
The customer returned the suspected contour meter and contour test strips for evaluation.The customer returned 6 bottles of contour test strips.Four of the returned bottles were from lot # 8lj3b03c, expiration date: 30-nov-2020, one of the returned bottles was from lot # 8ej3b03b, expiration date: 31-may-2020 and one of the returned bottles was from lot # 8ej3b01b, expiration date: 31-may-2020.The customer used test strips from lot # 8ej3b01b during the event.An in-house testing was performed using the returned meter with returned test strips from all the bottles, which gave satisfactory performance.Since the customer indicated that lot # 8ej3b01b was used during the event, sections d2 (common device name), d4 (model #, lot #, expiration date, and udi#), g1,2 (continued) - manufacturing site address, h4 (device manufacture date), and h5 (labeled for single use) have been updated with the product information related to test strips.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 9158038
• Report Number: 1810909-2019-00437
• Device Sequence Number: 1801246
• Product Code: NBW
• UDI-Device Identifier: 00301939545014
• UDI-Public: 00301939545014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 7080G
• Device Catalogue Number: 9545C
• Device Lot Number: 8EJ3B01B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 09/15/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 01/02/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/15/2019; 01/20/2020
• 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: Hospitalization