IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)

MDR report key: 7086080 · Received December 6, 2017

Report

Report Number: 1823260-2017-02851
Event Type: Malfunction
Date Received: December 6, 2017
Date of Event: November 15, 2017
Report Date: February 19, 2018
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFZ
PMA / PMN Number: K142133
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6).

Additional Manufacturer Narrative · 1

THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

Additional Manufacturer Narrative · 1

ON (B)(6) 2018, THE CUSTOMER REPEATED THE SAMPLE WITH NEW REAGENT LOT 268426 AND THE RESULT WAS 0.807 COI (BORDERLINE). THE REAGENT LOT NUMBER AT THE TIME OF ORIGINAL EVENT WAS 176724.

Additional Manufacturer Narrative · 1

THE SPECIFIC (B)(6) IGM RESULT WAS (B)(6). DATE OF EVENT AND - RELEVANT TEST/LABORATORY DATA WERE UPDATED.

Description of Event or Problem · 1

THE CUSTOMER RECEIVED A (B)(6) ELECSYS CMV IGM IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE. THE RESULT FROM A COBAS 6000 E 601 MODULE WAS (B)(6). NO SPECIFIC RESULT WAS PROVIDED. THE RESULT WAS REPORTED TO THE PATIENT'S PHYSICIAN, BUT AS IT WAS DISCREPANT FROM THE PREVIOUS RESULT FOR THE PATIENT THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED AND THE RESULT FROM VIDAS, LIASON XL, AND ANOTHER UNKNOWN ANALYZER WERE ALL (B)(6). NO SPECIFIC RESULTS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT'S DIAGNOSIS WAS NOT AFFECTED. THE ANALYZER SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
868714	IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS	LFZ	ROCHE DIAGNOSTICS	NA	176724

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR