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

Model Number 7321

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2017

Event Type  Injury  

Event Description

Advocate from (b)(6) stated her daughter fell asleep and at 9:30 pm when she took her to bed, she realized she was very weak and would not wake up.According to her contour next link log book her blood glucose readings at 9:20 and 9:23 pm were 6.6 and 7.2 mmol/l.She was very sick and had hypoglycemic symptoms.Advocate took her to the hospital where she was given iv dextrose.At 11:02 pm her blood glucose on the contour next link was 7.5.She was retested on the hospital meter and the reading was 2.2 mmol/l.At 12:04 the patient was tested on the hospital meter and her reading was 14.8 mmol/l.The difference between the readings falls in the "d" zone of the consensus error grid, making the difference clinically significant.The advocate was advised to return the strips for evaluation.A new meter was sent to the customer.

Manufacturer Narrative

The returned test strips were tested using blood targeted to 3.7 mmol/l and 7.4 mmol/l as determined by a ysi glucose analyzer.All returned test strip results with blood were high outside of the ffu limits.The returned test strips were also tested on an in-house contour xt (thp) meter using blood targeted to 67 mg/dl and 134 mg/dl as determined by a ysi glucose analyzer.All thp meter and returned test strip results with blood were also high outside of the ffu limits.The returned meter and in-house retained contour next strips (lot# dw6jfec31f) were also tested using blood targeted to 3.7 mmol/l and 7.4 mmol/l as determined by a ysi glucose analyzer.All results with in-house retained test strips were within the ffu limits.No high results were observed with the in-house retained test strips.The event is confirmed for high results with the returned strips, however the in-house retained test strips of the same lot gave acceptable performance.It is likely that the returned test strips were not stored properly by the customer and were exposed to a contaminant that caused the high results.Strips returned for evaluation have different lot# than those in the initial report.

• Brand Name: CONTOUR NEXT
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 430 s beiger st; mishawaka IN 46544
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s beiger st; mishawaka, IN 46544 ; 5743149617
• MDR Report Key: 6921606
• MDR Text Key: 88406532
• Report Number: 1826988-2017-00309
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 7321
• Device Lot Number: 6JFEC31F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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): Hospitalization; Required Intervention