inforMED
MalfunctionPER

BD FACS SAMPLE PREP ASSISTANT

Received Feb 16, 2021 · Event occurred Jan 16, 2021

Report 2916837-2021-00049 · MDR key 11332243

Device

Generic name

See H.10

Catalog number

650686

Lot number

NA

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED WHILE TESTING WITH A BD FACS¿ SAMPLE PREP ASSISTANT THE ABSOLUTE COUNTS ARE LOW FOR FIRST 6 PATIENT SAMPLES. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABSOLUTE COUNTS ARE LOW FOR THE FIRST ~6 SAMPLES AND THEN THEY START LOOKING NORMAL. THEY HAVE TRIED PRIMING NUMEROUS TIMES PRIOR TO RUNNING BUT THIS DOES NOT HELP. PATIENT SAMPLES CHECKLIST: 1) ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. 2) WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. 3) IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY TO TREATMENT? NOT APPLICABLE. 4) WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. (B)(6) : (B)(6) 2021 19:12:38 (GMT) REVIEWED, PENDING WO. MATERIAL NO: 650686 SERIAL NO: (B)(6). IT WAS REPORTED THAT THE ABSOLUTE COUNTS ARE LOW FOR THE FIRST ~6 SAMPLES. (B)(6): (B)(6) 2021 22:26:25 (GMT). IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: ABSOLUTE COUNTS ARE LOW FOR THE FIRST ~6 SAMPLES. CHRONICALLY THE FIRST SIX, OR SO, SAMPLES HAVE LOW CBC ABSOLUTE COUNTS. THE HAVE TRIED PRIMING NUMEROUS TIMES PRIOR TO RUNNING BUT THIS DOES NOT HELP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NONE, SHE MENTIONS THE FSE WAS THERE YESTERDAY FOR THE EXACT SAME ISSUE. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? N. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? N. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)? N/A. (B)(6): (B)(6) 2021 22:20:59 (GMT). ABSOLUTE COUNTS ARE LOW FOR THE FIRST ~6 SAMPLES AND THEN THEY START LOOKING NORMAL.

Additional Manufacturer Narrative

AFTER FURTHER REVIEW MFR#2916837-2021-00049 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED WHILE TESTING WITH A BD FACS¿ SAMPLE PREP ASSISTANT THE ABSOLUTE COUNTS ARE LOW FOR FIRST 6 PATIENT SAMPLES. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ABSOLUTE COUNTS ARE LOW FOR THE FIRST ~6 SAMPLES AND THEN THEY START LOOKING NORMAL. THEY HAVE TRIED PRIMING NUMEROUS TIMES PRIOR TO RUNNING BUT THIS DOES NOT HELP. PATIENT SAMPLES CHECKLIST. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY TO TREATMENT? NOT APPLICABLE. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.