A1CNOW SELFCHECK
Received Jul 31, 2013 · Event occurred Jul 1, 2013
Report 1826988-2013-00363 · MDR key 3256461
Device
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THREE MONITORS AND FIVE CARTRIDGES WERE RECEIVED AND TESTED BY QA: MONITOR "A" HAD ONLY ONE HISTORICAL READING OF 7.2%. MONITORS "B" AND "C" HAD NO SUCCESSFUL READINGS. BIO-RAD LYPHOCHEK CONTROL WAS RUN ON THE RETURNED PRODUCT AND THE READINGS WERE 0.6 AND 0.4% HIGH OUT OF SPEC. RETENTION LOT WAS ALSO TESTED WITH THE CONTROL AND THE READINGS WERE 0.2%, WITH LEVEL 1, AND 1.7% ,WITH LEVEL 2, HIGH OUT OF SPEC. THE ISSUE IF BEING INVESTIGATED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.
Description of Event or Problem
A PHARMACIST FROM (B)(6) HAD TESTED HIS BLOOD ON THE A1CNOW SELFCHECK KIT AND RECEIVED READINGS OF 6.5 AND 6.8%, WHICH HE FELT WAS TOO HIGH. NO ADVERSE EVENT WAS ALLEGED. THE COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED AT THE TIME OF THE CALL, BUT THE KIT WAS RETURNED FOR EVALUATION.