inforMED
MalfunctionOHQ

LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2

Received Nov 6, 2018 · Event occurred Oct 11, 2018

Report 2016706-2018-00005 · MDR key 8044607

Device

Generic name

Multi-analyte Control,unassayed ,product Code Ohq

Lot number

31872

Product problems

  • Human-Device Interface Problem
  • Human-Device Interface Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

ON (B)(6), A HEALTH COORDINATOR FROM THE (B)(6), CALLED BIO-RAD TO INQUIRE ABOUT LIQUICHEK UNASSAYED CHEMISTRY CONTAINING ANY INFECTIOUS DISEASE MATERIAL IN THE PRODUCT. SHE STATED THAT A TECHNICIAN SPLASHED A SMALL AMOUNT OF THE LEVEL 2 CONTROL INTO HER EYE WHILE PIPETTING THE CONTROL FROM THE PRIMARY VIAL INTO ANOTHER VIAL WHICH WAS GOING TO BE PLACED ON AN INSTRUMENT. THEY HAD THE TECHNICIAN FLUSHED OUT THE EYE WITH WATER FOR SEVERAL MINUTES. THEY ALSO CONDUCTED THE FOLLOWING MEDICAL TESTS: (B)(6). NO OTHER DETAILED INFORMATION WAS PROVIDED.

Description of Event or Problem

ON (B)(6), A HEALTH COORDINATOR FROM THE (B)(6), CALLED BIO-RAD TO INQUIRE ABOUT LIQUICHEK UNASSAYED CHEMISTRY CONTAINING ANY INFECTIOUS DISEASE MATERIAL IN THE PRODUCT. SHE STATED THAT A TECHNICIAN SPLASHED A SMALL AMOUNT OF THE LEVEL 2 CONTROL INTO HER EYE WHILE PIPETTING THE CONTROL FROM THE PRIMARY VIAL INTO ANOTHER VIAL WHICH WAS GOING TO BE PLACED ON AN INSTRUMENT. THEY HAD THE TECHNICIAN FLUSHED OUT THE EYE WITH WATER FOR SEVERAL MINUTES. THEY ALSO CONDUCTED THE FOLLOWING MEDICAL TESTS: (B)(6). NO OTHER DETAILED INFORMATION WAS PROVIDED.