SC+ QBL SOFTWARE

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 2 DEVICES HAD INVESTIGATION TYPES THAT HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 2 DEVICES WERE NOT REPROCESSED OR REUSED.

Description of Event or Problem

THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: HIGH READINGS. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99253. SUPPLEMENTAL RATIONALE: CORRECTED DATA: B5, H6, H11. 3 PREVIOUSLY REPORTED EVENTS WERE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS: 3 DEVICES WERE NOT AVAILABLE FOR EVALUATION. EVALUATION FINDINGS (RESULTS/COMPONENTS): 3 DEVICES: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION: 3 DEVICES: PRODUCT NOT RECEIVED.

Description of Event or Problem

NO CHANGE.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99253. SUPPLEMENTAL RATIONALE, CORRECTED DATA: B5, H1, H6, H11. 2 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER: HOWEVER, - 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED UNDER MFR REPORT # VMSR - 0894000005 - 1535 BUT SHOULD BE INCLUDED UNDER THIS REPORT. - 3 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS. 2 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS). 2 DEVICES: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION. 2 DEVICES: PRODUCT NOT RECEIVED. 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED.

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: HIGH READINGS. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.