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U.S. Department of Health and Human Services

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

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ASCENSIA DIABETES CARE US INC. CONTOUR NEXT ONE; BLOOD GLUCOSE METER Back to Search Results
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.
 
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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 Key9763221
MDR Text Key183482360
Report Number1810909-2020-00106
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K160682
Number of Events Reported1
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 Manufacturer02/26/2020
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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