inforMED
MalfunctionCGA

ACCU-CHEK ® INSTANT TEST STRIPS

Received Jul 17, 2024

Report 3011393376-2024-01482 · MDR key 19764810

Device

Generic name

Blood Glucose Monitoring Test Strips

Catalog number

07819382446

Lot number

302764

Product problems

  • Imprecise or Erratic Results
  • Imprecise or Erratic Results

Patient

NA · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H6 NO MATERIAL WILL BE RETURNED; CUSTOMER IS UNWILLING TO SEND IT. THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

Description of Event or Problem

IT WAS REPORTED THE PATIENT'S WIFE RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 183 MG/DL (CUSTOMER'S INSTANT SYSTEM) AND 97 MG/DL (PROFESSIONAL'S METER).