MEASLES IGG EIA

Report

Report Number: 3022521-2015-00006
Date Received: September 17, 2015
Date of Event: May 11, 2015
Report Date: June 28, 2017
Manufacturer: BIO-RAD LABORATORIES
Product Code: LJB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

ON (B)(6) 2015, BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL FROM A CUSTOMER TO REPORT THAT THE (B)(6) WAS TOO LOW AND THE (B)(6) IS ALSO OFTEN TOO LOW. IN INVESTIGATING THE ISSUE, TECH SUPPORT OBTAINED INFORMATION FROM THE CUSTOMER THAT THE CUSTOMER MANUALLY MODIFIES THE RUN WHEN THE CONTROL WELLS FAIL BY ADDING PART OF THE CONTENTS OF ANOTHER WELL ON THAT PLATE OR ANOTHER APPROPRIATELY COLORED WELL FOUND ON ANOTHER PLATE TO THE CONTROL WELL SO THAT THE WELL PASSES. RESULTS WERE REPORTED FROM THESE "MODIFIED" RUNS. UPON REVIEW OF DATA SENT BY THE CUSTOMER, IT WAS NOTED THAT THE "MODIFICATION" OF THE WELLS ALSO TOOK PLACE IN AN ADDITIONAL FOUR ASSAYS: MONOLISA ANTI-HBC EIA, MEASLES IGG EIA, MUMPS IGG EIA, AND ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM. BIO-RAD LABORATORIES SENT A LETTER TO THE CUSTOMER ON 5/21/2015 INFORMING THEM THAT THE PRACTICE OF "MODIFYING " RUNS IS AN UNACCEPTABLE LABORATORY PRACTICE AND IT WAS RECOMMENDED THAT THE CUSTOMER REPEAT ANY SAMPLES WHOSE RESULTS WERE REPORTED ON THOSE MODIFIED RUNS AND INFORM BIO-RAD LABORATORIES IF ANY INCORRECT RESULTS WERE REPORTED. A SECOND LETTER WAS SENT INFORMING THEM THAT ALL SHIPMENTS WILL BE SUSPENDED UNTIL THE TECHNICIAN IS RE-TRAINED ON THE EVOLIS INSTRUMENT BY A BIO-RAD DIAGNOSTIC SUPPORT SPECIALIST. THE CUSTOMER WAS CONTACTED TWO MORE TIMES BY BIO-RAD LABORATORIES OVER PHONE TO OBTAIN INFORMATION IF INCORRECT RESULTS WERE REPORTED. THE CUSTOMER HAD STATED THAT THEY HAD SENT A LETTER TO THE PROVIDERS FOR THE SAMPLES INCLUDED IN THE 5/13/2015 MONOLISA ANTI-HAV EIA OFFERING A NO-CHARGE REPEAT TEST FOR ANY SAMPLE RESULT THAT DID NOT AGREE WITH THE CLINICAL SYMPTOMS. THE CUSTOMER WAS ALSO PLANNING ON SENDING THE LETTERS TO PROVIDERS FOR SAMPLES INCLUDED IN THE 5/20/2015 MONOLISA ANTI-HAV EIA AND THE 5/13/2015 GS HBSAG EIA 3.0 RUN. IT IS NOT KNOWN IF THE PROVIDER SENT LETTERS TO PROVIDERS FOR MONOLISA ANTI-HBC EIA, MEASLES IGG EIA, MUMPS IGG EIA, AND ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM. RESULTS WERE RELEASED TO THE CARE PROVIDERS BY THE CUSTOMER AND WERE LIKELY RELEASED TO THE PATIENTS. GIVEN THE STRONG LIKELIHOOD THAT INCORRECT RESULTS WERE REPORTED, A MDR IS BEING SUBMITTED FOR THIS CASE TO EACH OF THE FIVE ASSAYS WE ARE RESPONSIBLE FOR REPORTING. BIO-RAD LABORATORIES DOES NOT HAVE REPORTING RESPONSIBILITY FOR ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM. THE MDR WILL BE EVALUATED BY ORTHO FOR MDR REPORTING.

Description of Event or Problem · 1

FOLLOW-UP #001 (ORIGINALLY SUBMITTED AS 3022521-2015-00008 ON 10/02/2015): UPON FURTHER REVIEW OF THE LABORATORY DATA, BIO-RAD LABORATORIES TECHNICAL SERVICES NOTED AND CONFIRMED ON 9/25/2015 THAT THE CUSTOMER DID NOT MODIFY THE ASSAY FOR MEASLES IGG EIA. THE MDR FILING FOR MEASLES IGG EIA WAS NOT NECESSARY. THIS ASSAY WAS THE ONLY ONE THAT WAS NOT MODIFIED BY THE CUSTOMER, BUT A MDR WAS SUBMITTED. THE CUSTOMER DID MODIFY MONOLISA ANTI-HAV EIA, GS HBSAG EIA 3.0 KIT, MONOLISA ANTI-HBC EIA, MUMPS IGG EIA, AND ORTHO® HCV VERSION 3.0 ELISA TEST SYSTEM. DESCRIPTION OF EVENT FROM 3022521-2015-00006: ON (B)(6) 2015, BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL FROM A CUSTOMER TO REPORT THAT THE NEGATIVE CONTROL FOR MONOLISA ANTI-HAV EIA WAS TOO LOW AND THE POSITIVE CONTROL FOR GS HBSAG EIA 3.0 KIT IS ALSO OFTEN TOO LOW. IN INVESTIGATING THE ISSUE, TECH SUPPORT OBTAINED INFORMATION FROM THE CUSTOMER THAT THE CUSTOMER MANUALLY MODIFIES THE RUN WHEN THE CONTROL WELLS FAIL BY ADDING PART OF THE CONTENTS OF ANOTHER WELL ON THAT PLATE OR ANOTHER APPROPRIATELY COLORED WELL FOUND ON ANOTHER PLATE TO THE CONTROL WELL SO THAT THE WELL PASSES. RESULTS WERE REPORTED FROM THESE "MODIFIED" RUNS. UPON REVIEW OF DATA SENT BY THE CUSTOMER, IT WAS NOTED THAT THE "MODIFICATION" OF THE WELLS ALSO TOOK PLACE IN AN ADDITIONAL FOUR ASSAYS: MONOLISA ANTI-HBC EIA, MEASLES IGG EIA, MUMPS IGG EIA, AND ORTHO® HCV VERSION 3.0 ELISA TEST SYSTEM. BIO-RAD LABORATORIES SENT A LETTER TO THE CUSTOMER ON 5/21/2015 INFORMING THEM THAT THE PRACTICE OF "MODIFYING " RUNS IS AN UNACCEPTABLE LABORATORY PRACTICE AND IT WAS RECOMMENDED THAT THE CUSTOMER REPEAT ANY SAMPLES WHOSE RESULTS WERE REPORTED ON THOSE MODIFIED RUNS AND INFORM BIO-RAD LABORATORIES IF ANY INCORRECT RESULTS WERE REPORTED. A SECOND LETTER WAS SENT INFORMING THEM THAT ALL SHIPMENTS WILL BE SUSPENDED UNTIL THE TECHNICIAN IS RE-TRAINED ON THE EVOLIS INSTRUMENT BY A BIO-RAD DIAGNOSTIC SUPPORT SPECIALIST. THE CUSTOMER WAS CONTACTED TWO MORE TIMES BY BIO-RAD LABORATORIES OVER PHONE TO OBTAIN INFORMATION IF INCORRECT RESULTS WERE REPORTED. THE CUSTOMER HAD STATED THAT THEY HAD SENT A LETTER TO THE PROVIDERS FOR THE SAMPLES INCLUDED IN THE 5/13/2015 MONOLISA ANTI-HAV EIA OFFERING A NO-CHARGE REPEAT TEST FOR ANY SAMPLE RESULT THAT DID NOT AGREE WITH THE CLINICAL SYMPTOMS. THE CUSTOMER WAS ALSO PLANNING ON SENDING THE LETTERS TO PROVIDERS FOR SAMPLES INCLUDED IN THE (B)(6) 2015 MONOLISA ANTI-HAV EIA AND THE (B)(6) 2015 GS HBSAG EIA 3.0 RUN. IT IS NOT KNOWN IF THE PROVIDER SENT LETTERS TO PROVIDERS FOR MONOLISA ANTI-HBC EIA, MEASLES IGG EIA, MUMPS IGG EIA, AND ORTHO® HCV VERSION 3.0 ELISA TEST SYSTEM. RESULTS WERE RELEASED TO THE CARE PROVIDERS BY THE CUSTOMER AND WERE LIKELY RELEASED TO THE PATIENTS. GIVEN THE STRONG LIKELIHOOD THAT INCORRECT RESULTS WERE REPORTED, A MDR IS BEING SUBMITTED FOR THIS CASE TO EACH OF THE FIVE ASSAYS WE ARE RESPONSIBLE FOR REPORTING. BIO-RAD LABORATORIES DOES NOT HAVE REPORTING RESPONSIBILITY FOR ORTHO® HCV VERSION 3.0 ELISA TEST SYSTEM. THE MDR WILL BE EVALUATED BY ORTHO® FOR MDR REPORTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
615341	MEASLES IGG EIA	IVD, EIA	LJB	BIO-RAD LABORATORIES		G1004

Patients

Seq	Age	Sex	Outcome	Treatment
1