COBAS® GLU TEST STRIPS

Additional Manufacturer Narrative

THE COBAS PULSE INSTRUMENT'S SERIAL NUMBER IS (B)(6). THE ACCU-CHEK INFORM II INSTRUMENT'S SERIAL NUMBER IS (B)(6). THE ACCU-CHEK INFORM TEST STRIP LOT NUMBERS ARE 671358 AND 671402. THE EXPIRATION DATES WERE NOT PROVIDED. THE PRODUCT WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR 1 PATIENT ON A COBAS® PULSE. THE RESULT ON THE COBAS PULSE INSTRUMENT WAS 35 MG/DL AT 11:12. THE NURSE QUESTIONED THE RESULT AND RETESTED THE PATIENT. AT 11:16, THE PATIENT WAS TESTED USING AN ACCU-CHEK INFORM II DEVICE, AND THE RESULT WAS 53 MG/DL WITH STRIP LOT 671402. AT 11:58, THE PATIENT WAS RETESTED. THE RESULT WITH THE COBAS PULSE INSTRUMENT WAS 45 MG/DL. AT 11:57, THE RESULT WITH THE ACCU-CHEK INFORM II DEVICE WAS 52 MG/DL WITH STRIP LOT 671358.

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. IT WAS NOTED THAT THE PUNCTURE SITE WAS NOT CLEANED, AND THE USER DID NOT WEAR GLOVES. QC WAS ACCEPTABLE. NO ABNORMALITIES WERE FOUND DURING RETENTION TESTING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

SECTION D4 EXPIRATION DATE WAS UPDATED.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR INVESTIGATION. RETENTION TEST STRIPS LOT 80306400 WERE TESTED WITH VENOUS BLOOD SAMPLES OF DIFFERENT HEMATOCRIT LEVELS ON THE RETURNED DEVICE AND ON A REFERENCE DEVICE. NO ABNORMALITIES WERE FOUND IN THE MEASUREMENT RESULTS. THE DEVICE WAS DISASSEMBLED FOR INSPECTION. SLIGHT TRACES OF CONTAMINATION (UNKNOWN LIQUID AND FOREIGN PARTICLES) ON THE EDGES OF THE UPPER AND LOWER STRIP CONTACTS WERE OBSERVED. THE EXACT REASON FOR THE OBSERVED DISCREPANCY COULD NOT BE CONCLUSIVELY DETERMINED WITHOUT THE RAW DATA. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.