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

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Itching Sensation (1943); Sweating (2444); Shaking/Tremors (2515)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

The customer returned the suspected contour next one meter for evaluation.No test strips were returned.An in-house testing was performed using the returned meter with in-house contour next test strips, which gave satisfactory performance.The customer stated that he sometimes scrapes the blood up with the test strip, rather than allowing the test strip to sip in the sample by capillary action.The customer also stated that sometimes he did not use soap to wash his hands prior to testing.As per contour next one user guide, "always wash your hands with soap and water and dry them well before and after testing or handling the meter, lancing device, or test strips." the user guide also states "immediately touch the tip of the test strip to the drop of blood.The blood is drawn into the test strip through the tip.Do not press the tip of the test strip against the skin or place the blood on top of the test strip.These actions could lead to inaccurate results or errors." 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.The model # was not provided.

Event Description

The customer from (b)(6) reported that at 5:15 a.M.He obtained a blood glucose reading of 204 mg/dl on the contour next one meter.Based on this reading, the customer took 66 units of insulin and ate breakfast.At 6:40 a.M., blood glucose reading of 44 mg/dl was obtained.The customer was experiencing symptoms of hypoglycemia such as itching, shakiness and sweating.The customer was visited by his nurse at this time as part of their daily routine.The nurse found that the customer was losing consciousness and gave him sugar solution after which he recovered well.The customer's doctor has since reduced his regular insulin dose from 76 to 72 units.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.The customer used all the test strips from the affected lot and disposed the bottle of test strips.Since the strip information was not provided, this report will be submitted under the meter information.

• Brand Name: CONTOUR NEXT ONE
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• Manufacturer (Section G): PT PHC INDONESIA (REGISTRATION #: 3009204541); kawasan industri mm2100; blok o-1, cikarang barat; bekasi, jawa barat, 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, ny ; 2361830
• MDR Report Key: 9763221
• MDR Text Key: 183482360
• Report Number: 1810909-2020-00106
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K160682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/30/2020

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR