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

Model Number	9740
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.
Event or Problem Description
At 6:15 a.M., the customer obtained a blood glucose reading of 482 mg/dl on his contour next link meter.The customer made a correction bolus for 12 units of insulin, as suggested by his insulin pump.At 8:34 a.M., the customer performed another test and obtained a blood glucose reading of 388 mg/dl.As the reading was still high, the customer made another correction bolus for 4.4 units of insulin.The customer started presenting the symptoms of low blood glucose level.Specific symptoms were not provided.Two hours later, while the customer was at the hospital for his regular visit, he passed out.At 10:17 a.M., his meter gave a blood glucose reading of 168 mg/dl.The customer was administered with an unknown dose of glucose through parenteral mode.The customer was tested with the physician's meter and a blood glucose reading of 265 mg/dl was obtained.At an unknown time, the customer performed a testing on his meter and obtained a blood glucose reading of 600 mg/dl.No action was taken based on this reading.Strips were not expected to be returned.Strip information was not provided.Replacement meter was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.

• Brand Name: CONTOUR NEXT LINK
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 430 s beiger st; mishawaka IN 46544
• MDR Report Key: 7839449
• Report Number: 1826988-2018-00211
• Device Sequence Number: 1249204
• Product Code: NBW
• UDI-Device Identifier: 00301939740013
• UDI-Public: 00301939740013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• 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
• Report Date (Section B): 08/15/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 9740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 08/31/2018
• 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: Required Intervention