MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGM IMMUNOASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number 04784618190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

The initial reporter questioned false negative elecsys cmv igm immunoassay results on a cobas 6000 e 601 module.The customer provided questionable test results for two patients.Refer to the attachment on the medwatch for all patient data.The e 601 cmv igm results were not reported outside the laboratory.Patient 1¿s first sample was only tested with elisa methodology.The following week, patient 1 had a new sample collected and the customer performed testing on the e 601 and two analyzers that used elisa methodology.Patient 2 was tested on the e 601 and an analyzer with elisa methodology.The e 601 serial number is (b)(4).

Manufacturer Narrative

The customer could not provide the patient's sample for further testing to complete the investigation.The customer's calibration and quality control data was requested but were not provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CMV IGM IMMUNOASSAY
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9855045
• MDR Text Key: 199229377
• Report Number: 1823260-2020-00782
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• PMA/PMN Number: K142133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 04784618190
• Device Lot Number: 43443401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1