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: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS NOT REPROCESSED OR REUSED.

Description of Event or Problem

THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS. 1 EVENT 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. SUPPLEMENTAL RATIONALE: CORRECTED DATA: B5, H1, H6, H11. 1 EVENT WAS PREVIOUSLY REPORTED DURING THE REPORTING PERIOD: HOWEVER, 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 3015967359-2025-99253. 0 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD.

Description of Event or Problem

THIS REPORT SUMMARIZES 0 EVENTS FOR THE FAILURE: INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS.