inforMED
MalfunctionGMQ

BD MACRO-VUE¿ RPR CARD TEST

Received Jun 16, 2023 · Event occurred May 26, 2023

Report 2647876-2023-00038 · MDR key 17148372

Device

Generic name

Antigens, Nontreponemal, All

Model number

275005

Catalog number

275005

Lot number

1306301

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

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2647876-2023-00038 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD MACRO-VUE¿ RPR CARD TEST, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOX 5/6 OF THE REAGENT THAT ARRIVED ON (B)(6) 2023 FROM RPR WAS OPENED, THE FIRST VIAL OF THE THREE THAT COMES IN THE BOX WAS USED. A REACTIVE SAMPLE WAS ANALYZED, WHICH WAS TITRATED, AND IT PRESENTED PERSISTENT AGGLUTINATION UP TO THE TITER 1/1028. GIVEN THIS SITUATION, WE PROCEEDED TO ANALYZE NON-REACTIVE PEEC SAMPLES, AND AT THE TIME OF ANALYSIS, THEY PRESENTED WEAK AGGLUTINATION OR AGGREGATION. A SECOND VIAL FROM THE SAME BOX WAS USED AND THE PROCESS WAS REPEATED, CONCLUDING IN THE SAME SITUATION. FINALLY, A VIAL FROM ANOTHER BOX WAS USED, AND IT WAS REPROCESSED WITH THE NON-REACTIVE PEEC SAMPLE, OBTAINING THE NON-REACTIVE RESULT, CONCLUDING THAT THE REAGENTS IN THAT BOX WERE POSSIBLY DEFECTIVE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH THE BD MACRO-VUE¿ RPR CARD TEST, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOX 5/6 OF THE REAGENT THAT ARRIVED ON 02-07-2023 FROM RPR WAS OPENED, THE FIRST VIAL OF THE THREE THAT COMES IN THE BOX WAS USED. A REACTIVE SAMPLE WAS ANALYZED, WHICH WAS TITRATED, AND IT PRESENTED PERSISTENT AGGLUTINATION UP TO THE TITER 1/1028. GIVEN THIS SITUATION, WE PROCEEDED TO ANALYZE NON-REACTIVE PEEC SAMPLES, AND AT THE TIME OF ANALYSIS, THEY PRESENTED WEAK AGGLUTINATION OR AGGREGATION. A SECOND VIAL FROM THE SAME BOX WAS USED AND THE PROCESS WAS REPEATED, CONCLUDING IN THE SAME SITUATION. FINALLY, A VIAL FROM ANOTHER BOX WAS USED, AND IT WAS REPROCESSED WITH THE NON-REACTIVE PEEC SAMPLE, OBTAINING THE NON-REACTIVE RESULT, CONCLUDING THAT THE REAGENTS IN THAT BOX WERE POSSIBLY DEFECTIVE.

Additional Manufacturer Narrative

H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.