Model Number STRIP, SUNMARK TMX 50CTMG/DL MM |
Device Problem
High Test Results (2457)
|
Patient Problem
Chest Pain (1776)
|
Event Date 05/06/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal report reference number: (b)(4).Outcomes attributed to adverse event: adverse event report is being submitted due to customer experiencing chest pain after administering insulin based on meter result.Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 17-may-2022 to ensure the customer's condition had improved and that the replacement products resolved the initial concern.Able to establish contact with customer who stated her condition had improved and she was not currently experiencing any diabetic symptoms.No medical intervention since the last call was reported.Customer stated that the replacement products resolved the initial concern.
|
|
Event Description
|
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from am fasting result obtained of 344 mg/dl.Customer was also concerned with am fasting meter to meter comparison results of 344 mg/dl using true metrix air meter and 242 mg/dl using true metrix meter.The customer¿s expected am fasting blood glucose test result is 230 mg/dl.Customer stated that she had administered insulin based on the result obtained of 344 mg/dl and that her chest currently feels heavy due to taking the medication.Medical attention was not needed at the time of the call.During the call, a back to back blood test was not performed by the customer; customer stated she had tested prior to call and had obtained a result of 229 mg/dl non-fasting.Customer stated the test strips are being stored using proper storage conditions and temperatures in her purse.The test strip lot manufacturer¿s expiration date is 08/31/2023 and test strips were opened three days prior to call.The meter memory was not reviewed for previous test result history.
|
|
Manufacturer Narrative
|
Sections with additional information as of 18-july-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.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 strips tested within specifications most likely underlying root cause: mlc-020: user's test strip had poor storage.
|
|
Search Alerts/Recalls
|