BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVD
Received Oct 23, 2020 · Event occurred Oct 4, 2020
Report 2916837-2020-00206 · MDR key 10726257
Device
Generic name
Mixture, Hematology Quality Control
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesModel number
349703Catalog number
349703
Lot number
BM1020
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
Additional Manufacturer Narrative
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. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH A BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVD RESULTS SHOW EXTRA POPULATION IN LOW CONTROL. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING EXTRA POPULATION PRESENT IN LOW CONTROL ONLY. NORMAL CONTROL LOOKS AS EXPECTED. REQUIRES A GATE ADJUSTMENT TO CORRECT FOR THIS. CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT. QUALITY IS AWARE OF THIS ISSUE AND IS INVESTIGATING. ADDITIONALLY, ON 2020-10-07 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT # 2916837-2020-00206 WAS SENT IN ERROR. ERROR WAS WITH CONTROL NOT PATIENT SAMPLES FOR CLINICAL USE, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH A BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVD RESULTS SHOW EXTRA POPULATION IN LOW CONTROL. THERE WAS NO IMPACT TO PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTING EXTRA POPULATION PRESENT IN LOW CONTROL ONLY. NORMAL CONTROL LOOKS AS EXPECTED. REQUIRES A GATE ADJUSTMENT TO CORRECT FOR THIS. CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT. QUALITY IS AWARE OF THIS ISSUE AND IS INVESTIGATING. ADDITIONALLY, ON 2020-10-07 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER HAS FOLLOWED UP THEY ORDERED 2 VIALS OF CATALOG 349703 LOT 1020 THAT SHOW THIS EXTRA POPULATION. THEY HAVE CONFIRMED THIS DID NOT AFFECT PATIENT DATA AS THEY NOTICED THE POPULATION AND WERE ABLE TO GATE THEM OUT.