Model Number STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL |
Device Problems
High Test Results (2457); Data Problem (3196)
|
Patient Problems
Weakness (2145); Urinary Frequency (2275); Diabetic Ketoacidosis (2364); Polydipsia (2604)
|
Event Date 08/23/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-18: user has high glucose value.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
|
|
Event Description
|
Consumer reported complaint for high blood glucose test results accompanied by symptoms and meter not storing results in meter memory.The customer is concerned with all test results obtained.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of extreme thirst, frequent urination and feeling weak.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored according to specification in the bedroom.During the call a blood test was performed by the customer and produced test results of 89mg/dl fasting using meter.The test strip lot manufacturer¿s expiration date is 04/30/2020 and open vial date is approximately one to two weeks ago.The meter memory was reviewed for previous test result history.(b)(6).
|
|
Manufacturer Narrative
|
Corrected section as of 23-oct-2019: h11: most likely underlying root cause changed from mlc-18: user has high glucose value to mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Most likely underlying root cause: mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.
|
|
Manufacturer Narrative
|
Internal report reference number: (b)(4).Sections with additional information as of 29-apr-2020: h6: updated fda's method, result, and conclusion codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Corrected sections as of 29-apr-2020: b2: adverse event report is being submitted due to symptoms related to diabetes - extreme thirst, frequent urination, and weakness.H1: type of reportable event corrected from "malfunction" to "serious injury".H3: device was returned to manufacturer for evaluation was corrected from "yes" to "no".
|
|
Search Alerts/Recalls
|