BD MULTI-CHECK¿
Report
- Report Number
- 2916837-2023-00107
- Event Type
- Malfunction
- Date Received
- May 22, 2023
- Date of Event
- May 3, 2023
- Report Date
- August 31, 2023
- Manufacturer
- BECTON DICKINSON AND COMPANY BD BIOSCIENCES
- Product Code
- GKZ
- UDI-DI
- 00382903409112
- PMA / PMN Number
- K961610
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00107 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.
E.7 INITIAL REPORTER ADDR 1: (B)(6). G.6 PMA / 510(K)# K961610, K982231. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING BD MULTI-CHECK¿ THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAS BEEN A CHANGE TO THE REFERENCE RANGE PRODUCT INSERT AND THE RUO RANGE VALUES ARE NO LONGER PROVIDED. THE CUSTOMER HAS NOT BEEN INFORMED OF THIS CHANGE WHICH IMPACTS THEIR PROCESS AND SOP.
IT WAS REPORTED THAT WHILE USING BD MULTI-CHECK¿ THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAS BEEN A CHANGE TO THE REFERENCE RANGE PRODUCT INSERT AND THE RUO RANGE VALUES ARE NO LONGER PROVIDED. THE CUSTOMER HAS NOT BEEN INFORMED OF THIS CHANGE WHICH IMPACTS THEIR PROCESS AND SOP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829534 | BD MULTI-CHECK¿ | NA | GKZ | BECTON DICKINSON AND COMPANY BD BIOSCIENCES | 340911 | BM0523N | 00382903409112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |