FDA Adverse Event Malfunction Summary report: N

IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)

MDR report key: 6991019 · Received October 31, 2017

Report

Report Number: 1823260-2017-02493
Event Type: Malfunction
Date Received: October 31, 2017
Date of Event: October 11, 2017
Report Date: November 9, 2017
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFZ
PMA / PMN Number: K142133
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AS NO SAMPLE MATERIAL WAS AVAILABLE FOR FURTHER INVESTIGATION, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. REVIEW OF THE PROVIDED CALIBRATION, QC, AND ANALYZER DATA DID NOT INDICATE ANY PRODUCT PROBLEM.

Additional Manufacturer Narrative · 1

(B)(4). THIS EVENT OCCURRED IN (B)(6) .

Description of Event or Problem · 1

THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS CMV IGM IMMUNOASSAY RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATEDLY NON-REACTIVE AND A RESULT OF 0.441 COI WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS THEN TESTED FOR CMV AVIDITY WITH AN ABBOTT METHOD AND THE RESULT WAS LOW AVIDITY (INDEX 3.27). BOTH THE CMV IGM AND IGG RESULTS WERE REACTIVE BY THE ABBOTT METHOD. NO SPECIFIC RESULTS WERE PROVIDED. THE SAMPLE WAS THEN TESTED BY PCR AND THE VIRAL LOAD WAS 85000 COPIES/ML. A SECOND BLOOD DRAW OBTAINED AT A LATER DATE ALSO HAD NEGATIVE CMV IGM RESULTS BY THE ROCHE METHOD. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER USED A MODULAR E MODULE (EVO) ANALYZER. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
770940	IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS	LFZ	ROCHE DIAGNOSTICS	NA	21691601

Patients

Seq	Age	Sex	Outcome	Treatment
1