BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
Report
- Report Number
- 1917413-2023-00424
- Event Type
- Malfunction
- Date Received
- May 12, 2023
- Date of Event
- January 1, 2022
- Report Date
- August 4, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- PJE
- PMA / PMN Number
- K972075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED PHOTOS OR CUSTOMER RETURNED SAMPLES FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. CERTAIN ASSAYS, IN THIS CASE HIV TESTING, ARE EXCLUDED FROM BD CLINICAL LABORATORY PROTOCOLS. THEREFORE, WE ARE AT THE PRESENT TIME, UNABLE TO PERFORM INTERNAL TESTING FOR INFECTIOUS DISEASES. HOWEVER, A BD STUDY CONCLUDED THAT THE BD VACUTAINER® PPT¿ IS EQUIVALENT TO EDTA PLASMA FOR HIV-1 VIRAL LOAD (AS MEASURED BY THE ROCHE TAQMAN HIV-1 VIRAL LOAD ASSAY [CAP/CTM]) IF WHOLE BLOOD IS STORED IN PPT FOR NO LONGER THAN 6 HOURS AT AMBIENT TEMPERATURE, PLASMA IS STORED IN PPT FOR NO LONGER THAN 1 DAY AT AMBIENT TEMPERATURE OR 5 DAYS AT 4°C, AND PPT IS RE-CENTRIFUGED AT 600 X G FOR 5 MINUTES IN THE RECEIVING LABORATORY PRIOR TO ALIQUOTING, TESTING, OR FURTHER STORAGE. ADDITIONALLY, AS COMPARED TO EDTA PLASMA, VIRAL LOADS ARE INCREASED IN A SIGNIFICANT NUMBER OF SAMPLES IN PPT NEAR OR BELOW THE LOQ WHEN PPT WAS INVERTED AND NOT RE-CENTRIFUGED. THEREFORE IT IS CRITICAL TO RE-CENTRIFUGE SAMPLES AFTER TRANSPORT.
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT DURING TESTING WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AN ERRONEOUS HIV RESULT WAS OBTAINED. INFORMATION REGARDING ANY CONFIRMATORY TESTING OR PATIENT IMPACT HAS NOT BEEN OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DATE OF OCCURRENCE: (B)(6) 2022. DESCRIPTION OF INCIDENT: WE STRONGLY SUSPECT THAT THESE TUBES MAY CAUSE ERRONEOUS HIV VIRAL LOAD TEST RESULTS AFTER THE TRANSPORT OF THE TUBES, WITH AN OVERESTIMATION OF THE RESULTS. INDEED, WE FOUND THAT SOME PATIENTS WITH KNOWN UNDETECTABLE VIRAL LOAD HAD A WEAKLY POSITIVE VIRAL LOAD SINCE THE USE OF THE INCRIMINATED TUBES.
IT WAS REPORTED THAT DURING TESTING WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AN ERRONEOUS HIV RESULT WAS OBTAINED. INFORMATION REGARDING ANY CONFIRMATORY TESTING OR PATIENT IMPACT HAS NOT BEEN OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DATE OF OCCURRENCE: (B)(6) 2022. DESCRIPTION OF INCIDENT: WE STRONGLY SUSPECT THAT THESE TUBES MAY CAUSE ERRONEOUS HIV VIRAL LOAD TEST RESULTS AFTER THE TRANSPORT OF THE TUBES, WITH AN OVERESTIMATION OF THE RESULTS. INDEED, WE FOUND THAT SOME PATIENTS WITH KNOWN UNDETECTABLE VIRAL LOAD HAD A WEAKLY POSITIVE VIRAL LOAD SINCE THE USE OF THE INCRIMINATED TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031276 | BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG | BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING | PJE | BECTON, DICKINSON & CO. (BROKEN BOW) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |