ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT

Additional Manufacturer Narrative

COMPLAINT INVESTIGATION WILL BE PERFORMED. LOT, EXPIRATION, UDI, MANUFACTURE DATE AND PMA NUMBER HAVE BEEN LEFT BLANK AS THIS MDR IS BEING SUBMITTED ON THE BASIS THAT ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT (2G28-91) IS SIMILAR TO THE ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT (8L07-91) SOLD IN THE UNITED STATES. TICKET DOES NOT REFERENCE A US LIST 8L07-91 LOT NUMBER.

Description of Event or Problem

THE ABBOTT REALTIME CT/NG ASSAY IS AN IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY FOR THE DIRECT, QUALITATIVE DETECTION OF THE PLASMID DNA FOR (B)(6) AND THE GENOMIC DNA OF (B)(6) IN FEMALE ENDOCERVICAL OR VAGINAL SWAB SPECIMENS, MALE URETHRAL SWAB SPECIMENS, OR IN MALE AND FEMALE URINE SPECIMENS. CUSTOMER INFORMED ABBOTT THAT DURING HANDLING OF PATIENT SAMPLE (URINE) INSIDE A MULTI-COLLECT SPECIMEN COLLECTION TUBE, THE SAMPLE SPLASHED INTO THE CUSTOMER'S EYE. THE CUSTOMER DID NOT WEAR PROTECTIVE GOGGLES. CUSTOMER WAS INSTRUCTED AS PER LATEST MATERIAL SAFETY DATA SHEET TO RINSE THE EYE WITH AN EYE SHOWER AND TO INFORM A DOCTOR. CUSTOMER WASHED THE EYE WITH THE EYE SHOWER FOR 10-20 MINUTES. EYE WAS IRRITATED AND RED. THE CUSTOMER RECEIVED ANTIBIOTIC TREATMENT AS IT WAS NOT KNOWN AT THAT TIME, IF THE SAMPLE WAS (B)(6). PATIENT SAMPLE WAS TESTED AND WAS DETERMINED TO BE (B)(6) FOR BOTH (B)(6) AND (B)(6). CUSTOMER FULLY RECOVERED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING REALTIME CT/NG LIST NUMBER 2G28-91 WHICH IS SAME/ SIMILAR TO US FDA APPROVED REALTIME CT/NG LIST NUMBER 8L07-91 .

Additional Manufacturer Narrative

INVESTIGATION INTO THIS COMPLAINT INCLUDED EVALUATION OF EXISTING DATA, QUALITY DATA REVIEW AND COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: EXISTING DATA REVIEW - SUPPORTING INFORMATION REVIEW: LABELING REVIEW CONCLUDED THAT THE RELATED LABELING IS SUFFICIENT TO ADDRESS THE REPORTED COMPLAINT. QUALITY DATA REVIEW: A DEVICE HISTORY RECORD/BATCH RECORD REVIEW WAS NOT PERFORMED AS THIS WAS NOT A LOT-SPECIFIC ISSUE. CORRECTIVE AND PREVENTIVE ACTION (CAPA)/ NON-CONFORMANCE REVIEW OF ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT (CONTAINING PIERCEABLE CAP) LIST 09K12-02 WAS PERFORMED BY AM TECHNICAL PRODUCT SUPPORT. THE CAPA REVIEW DID NOT IDENTIFY ANY RECORDS RELATED TO A PERSONAL INJURY OR ANYTHING SPLASHING INTO SOMEONE'S EYE. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW IDENTIFIED 1 ADDITIONAL COMPLAINT TICKET RELATED TO THE REPORTED ISSUE FOR ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT (CONTAINING PIERCEABLE CAP) LIST 09K12-02. TICKET WAS INVESTIGATED INDEPENDENTLY AND NO PRODUCT DEFICIENCY WAS FOUND. A RETAINED FILE SAMPLE EVALUATION WAS NOT PERFORMED AS THIS IS A PERSONAL INJURY ISSUE THAT OCCURRED WHILE HANDLING A PATIENT SAMPLE. CUSTOMER RETURNS WERE NOT AVAILABLE. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT (CONTAINING PIERCEABLE CAP) LIST 09K12-02 AND ABBOTT REALTIME CT/NG II (LIST 02G28-91) WAS NOT IDENTIFIED.