BD MACRO-VUE¿ RPR CARD TEST
Received Dec 2, 2022 · Event occurred Nov 4, 2022
Report 2647876-2022-00230 · MDR key 15901602
Device
Generic name
Antigens, Nontreponemal, All
Manufacturer
Becton Dickinson Caribe Ltd.Model number
275005Catalog number
275005
Lot number
2094445
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
CLARIFYING INFORMATION PROVIDED BY THE INITIAL REPORTER INDICATES THAT BECAUSE OF THE ISSUE WITH THE NEGATIVE CONTROL, THE RESULTS WERE NOT CONSIDERED VALID AND WERE NOT REPORTED TO A CLINICIAN. TESTING WAS REPEATED WITH A NEW LOT. THE PREVIOUS MFR REPORT #2647876-2022-00230 SHOULD BE CONSIDERED CANCELED.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD MACRO-VUE¿ RPR CARD TEST, ERRONEOUS RESULTS WERE OBTAINED. ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN, BUT THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEGATIVE CONTROL IS AGAIN CLOUDY AND ALSO SOME OF THE SAMPLE SO IT IS DIFFICULT TO DECIDE IF THE SAMPLE IS POSITIVE OR NEGATIVE. THE AGGLUTINATION REAGENT HAVE THE SAME LOT NUMBER IN ALL KITS. WHEN YOU LOOK AT THE TUBES IN THE KITS THE LIQUID IS WITH SEDIMENTATION /GRANULAR IN IT AND IT DIFFERS HOW MUCH SEDIMENTATION IS BETWEEN TUBES.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD MACRO-VUE¿ RPR CARD TEST, ERRONEOUS RESULTS WERE OBTAINED. ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN, BUT THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEGATIVE CONTROL IS AGAIN CLOUDY AND ALSO SOME OF THE SAMPLE SO IT IS DIFFICULT TO DECIDE IF THE SAMPLE IS POSITIVE OR NEGATIVE. THE AGGLUTINATION REAGENT HAVE THE SAME LOT NUMBER IN ALL KITS. WHEN YOU LOOK AT THE TUBES IN THE KITS THE LIQUID IS WITH SEDIMENTATION /GRANULAR IN IT AND IT DIFFERS HOW MUCH SEDIMENTATION IS BETWEEN TUBES.
Additional Manufacturer Narrative
INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.