ACCU-CHEK ® INSTANT TEST STRIPS
Received Oct 15, 2024 · Event occurred May 23, 2024
Report 3011393376-2024-02140 · MDR key 20454840
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
1 DA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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
A PEDIATRICIAN REPORTED A LOW BIRTH WEIGHT NEONATAL PATIENT WAS ADMITTED DUE TO RESPIRATORY DISTRESS AND RISK OF HYPOGLYCEMIA. A BLOOD GAS ANALYSIS RESULT WAS 27 MG/DL WHILE THE BLOOD GLUCOSE METER PROVIDED A READING OF 43 MG/DL AT THE SAME TIME. AT 7 HOURS OF LIFE THE PATIENT AGAIN PRESENTED WITH HYPOGLYCEMIA AND THE CAPILLARY GAS ANALYSIS RESULT WAS 30 MG/DL WITH A BLOOD GLUCOSE METER RESULT OF 43 MG/DL AT THE SAME TIME. CLINICAL DECISIONS WERE TAKEN BASED ON RESULTS OF THE BLOOD GLUCOSE METER DUE TO SLOW LAB RESPONSE WITH BLOOD GAS ANALYZER RESULTS.