FDA Adverse Event Malfunction Summary report: N

ID CORE XT

MDR report key: 10230738 · Received July 3, 2020

Report

Report Number: 3006413195-2020-00008
Event Type: Malfunction
Date Received: July 3, 2020
Date of Event: May 22, 2020
Report Date: July 3, 2020
Manufacturer: PROGENIKA BIOPHARMA S.A.
Product Code: PEP
UDI-DI: 08437013457019
PMA / PMN Number: BP170154
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE GENOMIC DNA SAMPLE WAS SENT TO GRIFOLS IH CENTER FOR SEQUENCING. NEXT GENERATION SEQUENCING INTERROGATED JK GENE PROXIMAL PROMOTER AND EXONS 1-10 AND THE GENOTYPE JK*A(28A, 226A, 303A), JK*B WAS IDENTIFIED. ISBT DESCRIBES VARIANT JK*A: C. (28G>A) AS JK*01W.03 ASSOCIATED TO JKA+W. ISBT DESCRIBES VARIANT JK*A: C. (226G>A) AS JK*01W.04 ASSOCIATED TO JKA+W. ISBT DESCRIBES VARIANTS JK*A: C.28G>A, JK*A: C.226G>A , JK*A: C.303G>A AND JK*A: C.588A>G AS ALLELE JK*01N.20 ASSOCIATED TO JKA-. THIS LAST ASSOCIATION ALTHOUGH NOT COMPLETE IS IN CONCORDANCE WITH SEROLOGY RESULT JKA-. ID CORE XT REPORTED A PREDICTED JKA+ PHENOTYPE, BUT SEROLOGY TEST REPORTED JKA- RESULT, DUE TO THE PRESENCE OF VARIANTS JK*A: C.28G>A, JK*A: C.226G>A AND JK*A: C.303G>A PREVIOUSLY DESCRIBED AS LIKELY ASSOCIATED TO JKA-. THIS FALSE POSITIVE RESULT OBTAINED BY ID CORE XT IS CONSIDERED A DISCREPANT RESULT AND THEN A MALFUNCTION. THIS LIMITATION IS COVERED BY THE GENERAL ASSAY LIMITATIONS DESCRIBED IN THE ID CORE XT PACKAGE INSERT (LIMITATIONS 1 AND 10).

Description of Event or Problem · 1

THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SEROLOGICAL PHENOTYPE WAS JKA NEGATIVE AND THE ID CORE XT GENOTYPE SUGGESTED A PHENOTYPE OF JKA POSITIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
692492	ID CORE XT	ID CORE XT	PEP	PROGENIKA BIOPHARMA S.A.	1291720000	0203000019	08437013457019

Patients

Seq	Age	Sex	Outcome	Treatment
1