MalfunctionCGA

ACCU-CHEK ® INSTANT

Received Dec 6, 2024 · Event occurred Nov 22, 2024

Report 3011393376-2024-02457 · MDR key 20867928

Device

Generic name

Blood Glucose Monitoring Test Strips

Manufacturer

Roche Diabetes Care, Inc.

Catalog number

07819382020

Lot number

303008

Product problems

High Test Results
High Test Results

Patient

NA · Female

Hypoglycemia
Hypoglycemia

Narrative

Additional Manufacturer Narrative

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 RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 225 MG/DL (SYSTEM 1) AND 100 MG/DL (SYSTEM 2), WHILST HAVING NOT SPECIFIED HYPOGLYCEMIA SYMPTOMS.