BD MULTITEST¿
Report
- Report Number
- 3008352382-2024-00001
- Event Type
- Malfunction
- Date Received
- March 15, 2024
- Date of Event
- February 8, 2024
- Report Date
- August 27, 2024
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- GKZ
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED PERFORMANCE ISSUE WAS CONFIRMED BUT NOT ATTRIBUTED TO TBNK REAGENT PERFORMANCE. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: BHR REVIEW AND LATER MATERIAL USAGE DATA AS A REFERENCE BATCH SHOWING ACCEPTABLE PERFORMANCE. RETAIN SAMPLE TESTING SHOWING ACCEPTABLE PERFORMANCE. POTENTIAL CAUSE FOR CUSTOMER REPORTED COMPLAINT WAS NOT DETERMINED. 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.
D.4. MEDICAL DEVICE EXPIRATION DATE: NA. G.5. PMA / 510(K)#: K090967. G.5. PMA / 510(K)#: K170974. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CONTAMINATION DEBRIS WHILE USING PRODUCT 662967 (BD MULTITEST 6-COLOR TBNK REAGENT, IVD) LOT 34028 WAS NOT CONFIRMED AS IS NOT ATTRIBUTED TO TBNK REAGENT PERFORMANCE. INVESTIGATION RESULTS WERE PERFORMED ON THE INDICATED FAILURE MODE FOUND PRODUCT PERFORMED AS INTENDED PER BD BIOSCIENCES SPECIFICATIONS DURING RELEASE TESTING, EXAMINED CUSTOMER PROVIDED DATA AND RECENT RETAIN TESTING DID NOT REPRODUCED REPORTED DEFECT. THE CAUSE FOR REPORTED COMPLAINT COULD NOT BE DETERMINED AFTER INVESTIGATION, HOWEVER, COULD BE ATTRIBUTED TO UNINTENDED USE ERROR BY CUSTOMER. 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.
IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS LOT(34028) IS STAINED, IN THE CD45 VS SSC , ,CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. WHEN DID THIS INCIDENT OCCUR? DURING USE: ERRONEOUS RESULTS-YES.
IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS LOT(34028) IS STAINED, IN THE CD45 VS SSC , ,CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. WHEN DID THIS INCIDENT OCCUR? DURING USE : ERRONEOUS RESULTS-YES.
IT WAS REPORTED THAT WHILE USING BD MULTITEST¿ ERRONEOUS RESULTS WERE OBSERVED. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS LOT(34028) IS STAINED, IN THE CD45 VS SSC,CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. WHEN DID THIS INCIDENT OCCUR? DURING USE : ERRONEOUS RESULTS-YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1320108 | BD MULTITEST¿ | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON DICKINSON CARIBE LTD. | 34028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |