KALLSTEAD HEP-2 AND ANCA
Received Nov 15, 2018 · Event occurred Nov 7, 2018
Report 1000135116-2018-00001 · MDR key 8075780
Device
Generic name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Manufacturer
Bio-rad Laboratories, Inc.Model number
N/ACatalog number
29403, 32583
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
Narrative
Description of Event or Problem
CUSTOMER IS A NURSE. WHEN OPENING THE FRIDGE, ANCA OR HEP-2 SLIDES FELL (ABOUT 4 TO 5 SLIDES). ATTEMPTING TO PICK UP THE BROKEN SLIDES THE CUSTOMER CUT HERSELF ALTHOUGH SHE WAS WEARING PROTECTIVE GLOVES. THE CUSTOMER WASHED HER HANDS THOROUGHLY WITH SOAP AND LEFT HER FINGER IN THE ALCOHOL FOR ABOUT 40 MINUTES. A SEROLOGY CHECK WILL BE DONE IN 7 WEEKS. THE CUSTOMER WENT TO SEE A DOCTOR. THE DOCTOR HAS ASSURED THE CUSTOMER THAT THERE IS NO HIV RISK , BECAUSE THE SLIDES WERE OLD AND DATED AS OF 2012. CUSTOMER WAS INJURED ON (B)(6) 2018. (B)(6) CUSTOMER REP (B)(6) WILL CONTACT CUSTOMER FOR FOLLOWUP INFORMATION IN 7 WEEKS.