BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
Report
- Report Number
- 2647876-2024-00044
- Event Type
- Malfunction
- Date Received
- March 8, 2024
- Date of Event
- January 17, 2024
- Report Date
- August 1, 2024
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- GKZ
- PMA / PMN Number
- K970836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: G.4. DATE RECEIVED BY MANUFACTURER: INFORMATION OBTAINED FROM CUSTOMER MAKING COMPLAINT REPORTABLE WAS RECEIVED 09-FEB-2024.
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: D4. UNIQUE IDENTIFIER: (B)(4). H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED SURRESTIMATION (OVERESTIMATION) OF ABSOLUTE COUNT WAS CONFIRMED TO BE A USAGE ERROR. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: TESTING ON 91-0786 BATCH 23128 MATERIAL DESCRIPTION POUCHED ABSOLUTE COUNT TUBES WAS PERFORMED WITHIN 6 MONTHS OF THE COMPLAINT, THE RESULTS SHOWED THAT THE PRODUCT WAS PERFORMING AS INTENDED. BHR REVIEW AND LATER MATERIAL USAGE DATA AS A REFERENCE BATCH SHOWING ACCEPTABLE PERFORMANCE. POTENTIAL CAUSE FOR CUSTOMER REPORTED COMPLAINT WAS DETERMINED TO BE THE USE OF A NON-BD INSTRUMENT WITH A BD REAGENT, THIS IS A NOT SUPPORTED APPLICATION AS PER BD TRUCOUNTTM TUBES IFU (PART NO. 23-3483(16); "INTENDED USE" SECTION). 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 DURING USE WITH BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBTAINED. NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVE SURRESTIMATION OF ABSOLUTE COUNTING ON ITS BD FACSLYRIC ON FACSUITE CLINICAL SOFTWARE AS COMPARED WITH NUMERATION ON ITS SYSMEX HEMATOCYTOMETER.
IT WAS REPORTED THAT DURING USE WITH BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBTAINED. NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVE SURRESTIMATION OF ABSOLUTE COUNTING ON ITS BD FACSLYRIC ON FACSUITE CLINICAL SOFTWARE AS COMPARED WITH NUMERATION ON ITS SYSMEX HEMATOCYTOMETER.
IT WAS REPORTED THAT DURING USE WITH BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES ERRONEOUS RESULTS WERE OBTAINED. NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVE SURRESTIMATION OF ABSOLUTE COUNTING ON ITS BD FACSLYRIC ON FACSUITE CLINICAL SOFTWARE AS COMPARED WITH NUMERATION ON ITS SYSMEX HEMATOCYTOMETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 696260 | BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES | COUNTER, DIFFERENTIAL CELL | GKZ | BECTON DICKINSON CARIBE LTD. | 3186043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |