MalfunctionCGA

ACCU-CHEK ® INSTANT

Received Dec 10, 2024 · Event occurred Oct 30, 2024

Report 3011393376-2024-02479 · MDR key 20897262

Device

Generic name

Blood Glucose Monitoring Test Strips

Manufacturer

Roche Diabetes Care, Inc.

Catalog number

07819382020

Lot number

302296

Product problems

High Test Results
High Test Results

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

CORRECTION - THE MANUFACTURING SITE INFORMATION WAS UPDATED IN SECTION G1.

Description of Event or Problem

IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 306 MG/DL WITH THE INSTANT SYSTEM AND 128 MG/DL WITH A LABORATORY DEVICE.

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.