CELL-DYN RUBY SYSTEM
Report
- Report Number
- 2919069-2023-00041
- Event Type
- Malfunction
- Date Received
- November 10, 2023
- Date of Event
- August 11, 2023
- Report Date
- August 15, 2024
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- GKZ
- UDI-DI
- 00380740017170
- PMA / PMN Number
- K061667
- Removal / Correction Number
- 1415939-10/31/23-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION FOR SECTION D: CELL-DYN SAPPHIRE LN 08H00-01. D1 BRAND NAME: CELL-DYN SAPPHIRE. D2 COMMON DEVICE NAME: COUNTER, DIFFERENTIAL CELL. D2B PRODUCT CODE: GKZ. LEGAL MANUFACTURE: ABBOTT LABORATORIES, 4551 GREAT AMERICA PARKWAY, SANTA CLARA, CA, 95054. D4- CATALOG#: 08H00-01. D4 UDI: (B)(4). ADDITIONAL INFORMATION FOR SECTION G4-PMA/510(K)#: K051215 FOR CELL-DYN SAPPHIRE. ADDITIONAL INFORMATION FOR SECTION H4 DEVICE MFG DATE: CELL-DYN RUBY MANUFACTURING DATE RANGE: 06/12/2006-09/04/2023. CELL-DYN SAPPHIRE MANUFACTURING DATE RANGE: 03/31/2005-09/22/2020. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION. A PRODUCT CORRECTION LETTER WAS ISSUED ON 19OCT2023 TO ALL CELL-DYN RUBY AND SAPPHIRE CUSTOMERS, NOTIFYING THEM OF THE REQUIRED LABELING UPDATE TO IDENTIFY THE PRODUCT CONTAINS LATEX. THE PRODUCT CORRECTION LETTER INFORMS THE CUSTOMER THAT AN ABBOTT REPRESENTATIVE WILL SCHEDULE A SERVICE VISIT WHEN THE INSTRUMENT LABEL IS AVAILABLE FOR APPLICATION AS WELL AS THE NECESSARY ACTIONS UNTIL THE LABEL IS APPLIED. H3 OTHER TEXT : INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
THIS MDR IS BEING SUBMITTED TO CORRECT A STATEMENT PREVIOUSLY POPULATED IN THE H10- ADDITIONAL MFG NARRATIVE SECTION OF THE INITIAL REPORT. THE REPORT INADVERTENTLY INCLUDED ¿A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.¿ THIS STATEMENT IS BEING CORRECTED TO ¿NO SUPPLEMENTAL REPORT IS REQUIRED AS INVESTIGATIONAL FINDINGS WILL BE REPORTED UNDER CORRECTION/REMOVAL REPORT NUMBER 1415939-10/31/23-001-C WHEN THE INFORMATION IS AVAILABLE.¿ NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER.
A GLOBAL ASSESSMENT WAS PERFORMED FOLLOWING THE IDENTIFICATION THAT THE ABBOTT ALINITY S SYSTEM CONTAINS A DRY NATURAL RUBBER (LATEX) SUBCOMPONENT, WHICH IS NOT LABELED AS CONTAINING DRY NATURAL RUBBER (LATEX), TO DETERMINE IF THERE IS ANY IMPACT ON OTHER ABBOTT PRODUCTS. THE GLOBAL ASSESSMENT IDENTIFIED THE CELL-DYN SAPPHIRE AND CELL-DYN RUBY CONTAIN A LATEX SUBCOMPONENT AND IS NOT LABELED AS CONTAINING LATEX. DIRECT CONTACT WITH THESE COMPONENTS HAS THE POTENTIAL TO CAUSE ALLERGIC REACTIONS. THERE HAS BEEN NO REPORTED ADVERSE IMPACT OR HARM TO THE USER/OPERATOR AS A RESULT OF THIS ISSUE TO THE DATE.
A GLOBAL ASSESSMENT WAS PERFORMED FOLLOWING THE IDENTIFICATION THAT THE ABBOTT ALINITY S SYSTEM CONTAINS A DRY NATURAL RUBBER (LATEX) SUBCOMPONENT, WHICH IS NOT LABELED AS CONTAINING DRY NATURAL RUBBER (LATEX), TO DETERMINE IF THERE IS ANY IMPACT ON OTHER ABBOTT PRODUCTS. THE GLOBAL ASSESSMENT IDENTIFIED THE CELL-DYN SAPPHIRE AND CELL-DYN RUBY CONTAIN A LATEX SUBCOMPONENT AND IS NOT LABELED AS CONTAINING LATEX. DIRECT CONTACT WITH THESE COMPONENTS HAS THE POTENTIAL TO CAUSE ALLERGIC REACTIONS. THERE HAS BEEN NO REPORTED ADVERSE IMPACT OR HARM TO THE USER/OPERATOR AS A RESULT OF THIS ISSUE TO THE DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104011 | CELL-DYN RUBY SYSTEM | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740017170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |