COBAS® GLU TEST STRIPS

Additional Manufacturer Narrative

THE MATERIAL WAS REQUESTED BUT NOT RECEIVED. THE TEST STRIPS FROM THE SAME CONTAINER HAVE ALREADY BEEN USED UP. THE CUSTOMER STATED THAT SUBSEQUENT PATIENTS WOULD HAVE THEIR BLOOD GLUCOSE VALUES CONFIRMED TWICE. THE CURRENT USAGE SITUATION IS NORMAL. A ROCHE FIELD APPLICATION SPECIALIST HAS CONDUCTED REPEATED TESTING ON THE PULSE DEVICE USING QC AND LINEARITY STANDARD REAGENTS, AND NO ABNORMALITIES HAVE BEEN FOUND. FOR TEST STRIP LOT 772788, NO ABNORMALITIES WERE OBSERVED FOR THIS TEST STRIP LOT. NO ABNORMALITIES WERE OBSERVED WHEN TESTING WITH SYRINGES DURING DEVELOPMENT. DIFFERENT SKIN DISINFECTANTS WERE TESTED, ONE OF THEM WAS SOFTA CLOTH CHX 2%. IT CONTAINS CHLORHEXIDIN. NO ABNORMALITIES OBSERVED. INSULIN WAS TESTED ACCORDING TO GUIDELINES UP TO 127MU/L, NO INTERFERING EFFECT, NO DEVIATIONS FOUND. PER PRODUCT LABELING, "IF THE BLOOD GLUCOSE RESULT DOES NOT REFLECT THE PATIENT¿S CLINICAL SYMPTOMS, OR SEEMS UNUSUALLY HIGH OR LOW, PERFORM A MEASUREMENT WITH THE QC MATERIAL. IF THIS MEASUREMENT CONFIRMS THAT THE SYSTEM IS WORKING PROPERLY, REPEAT THE BLOOD GLUCOSE TEST. IF THE SECOND BLOOD GLUCOSE RESULT STILL SEEMS UNUSUAL, FOLLOW FACILITY GUIDELINES FOR FURTHER ACTION." RETENTION MATERIAL WAS TESTED WITH THREE DIFFERENT VENOUS BLOOD SAMPLES. THEY WERE ADJUSTED TO CONCENTRATIONS UP TO 26-35 MG/DL PRIOR THE MEASUREMENTS AND MEASURED WITH RETENTION TEST STRIPS FROM LOT 77278800 ON COBAS PULSE INSTRUMENTS. ALL VALUES WERE COMPARED WITH THE HEXOKINASE REFERENCE METHOD ON COBAS 6000 ANALYZER. THE DEVIATIONS FROM THE REFERENCE METHOD FOR ALL BLOOD SAMPLES ARE APPROXIMATELY 0,3 TO 4,5%. DEVIATIONS OBSERVED BY THE CUSTOMER COULD NOT BE CONFIRMED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

Description of Event or Problem

ROCHE DIAGNOSTICS RECEIVED AN ALLEGATION THAT A PATIENT RECEIVED DISCREPANT GLUCOSE RESULTS WHEN TESTED WITH COBAS® PULSE INSTRUMENT SERIAL NUMBER (B)(6). THE PATIENT WAS BROUGHT INTO THE EMERGENCY ROOM IN A COMATOSE STATE. AT 8:35, A SAMPLE FROM THE PATIENT WAS TESTED USING THE COBAS PULSE, RESULTING IN A GLUCOSE VALUE OF 142 MG/DL. BASED ON THIS RESULT, THE CUSTOMER RULED OUT HYPOGLYCEMIA AS THE CAUSE. AT THE SAME TIME AS THE FIRST COBAS PULSE TEST, A SAMPLE FROM THE PATIENT WAS SENT TO THE LABORATORY FOR TESTING USING AN UNKNOWN METHOD. THE LABORATORY GLUCOSE RESULT WAS 19 MG/DL. AT 9:09, A SAMPLE FROM THE PATIENT WAS TESTED USING THE COBAS PULSE, RESULTING IN A GLUCOSE VALUE OF 17 MG/DL.

Additional Manufacturer Narrative

THE GLUCOSE TEST STRIP LOT NUMBER WAS 772788. THE TEST STRIP EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE CUSTOMER'S TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE MATERIAL HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. E1 INITIAL REPORTER ESTABLISHMENT NAME - THE FULL FACILITY NAME WAS PROVIDED AS (B)(6) HOSPITAL IS ENTRUSTED TO THE (B)(6) UNIVERSITY TO OPERATE (B)(6) HOSPITAL IS ENTRUSTED TO THE PRIVATE (B)(6) UNIVERSITY TO OPERATE."

Additional Manufacturer Narrative

THE GLUCOSE TEST STRIP EXPIRATION DATE WAS 18-NOV-2025. THE FIRST SAMPLE WAS COLLECTED USING A SYRINGE, AND THE SECOND SAMPLE WAS FROM A FINGERTIP BLOOD. THE TEST STRIPS WERE ALL USED UP. THE FIELD APPLICATION SPECIALIST CONDUCTED REPEATED TESTING ON THE COBAS PULSE DEVICE USING QC AND LINEARITY STANDARD REAGENTS, AND NO ABNORMALITIES WERE FOUND. THE INSTRUMENT WAS REQUESTED FOR INVESTIGATION ON 10-JAN-2025. THE INVESTIGATION IS ONGOING.