MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. KALLSTEAD HEP-2 AND ANCA; ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 11/07/2018

Event Type  Injury  

Event Description

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.

• Brand Name: KALLSTEAD HEP-2 AND ANCA
• Type of Device: ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 5500 east second street; benicia CA 94510
• Manufacturer (Section G): IMMCO DIAGNOSTIC, INC; 60 pineview dr; amherst NY 14228
• Manufacturer Contact: nghia luu ; 5500 east second street; benicia,
• MDR Report Key: 8075780
• MDR Text Key: 127347760
• Report Number: 1000135116-2018-00001
• Device Sequence Number: 1
• Product Code: DBM
• UDI-Device Identifier: 00847817016103
• UDI-Public: 00847817016103
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 29403, 32583
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other