inforMED
MalfunctionOYE

BD CD45(2D1) APC-H7

Received Aug 14, 2023 · Event occurred May 30, 2023

Report 2916837-2023-00167 · MDR key 17541999

Device

Generic name

Flow Cyytometric Reagents And Accessories

Catalog number

641417

Lot number

2363930

Product problems

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

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD CD45(2D1) APC-H7. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ANTIBODY IS USED AS PART OF 2 ANTIBODY PRE-MIX FOR IMMUNOPHENOTYPING STAINING. AFTER PERFORMING PRE-MIX CHECKS OVER THE PAST MONTH, WE HAVE OBSERVED DIFFERENCES IN CD45 BRIGHTNESS, SPECIFICALLY THE USE OF LOT 2363930 WOULD RESULT IN LOWER MFI COMPARED TO LOTS 2311097 AND 3060161. SAMPLE AVAILABILITY (YES/NO INCLUDING PICK UP DETAIL INFORMATION): 2 BOTTLES LEFT. WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? (GIVE DETAILED INFORMATION): NO. 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? 2. DID CARRYOVER HAPPEN ON PATIENT SAMPLES? 1. YES. 2. YES. WE ADDED THIS LOT IN MULTIPLE PREMIXES (PREPARED BY US) AND THEN USED IT FOR TESTING PATIENTS' SAMPLES. HOWEVER, AT THE MOMENT OF ANALYSIS, WE ADJUSTED OUR GATING STRATEGY TO AVOID THE LOW MFI AFFECTING RESULTS. SO EVEN IF THE DIFFERENT CD45 EXPRESSION HAS BEEN DETECTED IN PATIENTS SAMPLES, GATES HAVE BEEN MOVED TO AID THE CORRECT INTERPRETATION OF THE DATA.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD CD45(2D1) APC-H7. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ANTIBODY IS USED AS PART OF 2 ANTIBODY PRE-MIX FOR IMMUNOPHENOTYPING STAINING. AFTER PERFORMING PRE-MIX CHECKS OVER THE PAST MONTH, WE HAVE OBSERVED DIFFERENCES IN CD45 BRIGHTNESS, SPECIFICALLY THE USE OF LOT 2363930 WOULD RESULT IN LOWER MFI COMPARED TO LOTS 2311097 AND 3060161. ¿ SAMPLE AVAILABILITY (YES/NO INCLUDING PICK UP DETAIL INFORMATION): 2 BOTTLES LEFT. ¿ WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? (GIVE DETAILED INFORMATION): NO 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? 2. DID CARRYOVER HAPPEN ON PATIENT SAMPLES? 1. YES* 2. YES* *WE ADDED THIS LOT IN MULTIPLE PREMIXES (PREPARED BY US) AND THEN USED IT FOR TESTING PATIENTS' SAMPLES. HOWEVER, AT THE MOMENT OF ANALYSIS, WE ADJUSTED OUR GATING STRATEGY TO AVOID THE LOW MFI AFFECTING RESULTS. SO EVEN IF THE DIFFERENT CD45 EXPRESSION HAS BEEN DETECTED IN PATIENTS SAMPLES, GATES HAVE BEEN MOVED TO AID THE CORRECT INTERPRETATION OF THE DATA.

Additional Manufacturer Narrative

H.6 BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF DIFFERENCES IN CD45 BRIGHTNESS, LOT 2363930 RESULTED IN LOWER MFI COMPARED TO LOTS 2311097 AND 3060161 WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: ¿ DHR OR BHR REVIEW FOR MANUFACTURE BATCH RECORD AND QC TESTING RELEASE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.