MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM); ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number 04784618190

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

The specific (b)(6) igm result was (b)(6).Date of event and - relevant test/laboratory data were updated.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• Brand Name: IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7086080
• MDR Text Key: 95010753
• Report Number: 1823260-2017-02851
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K142133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04784618190
• Device Lot Number: 176724
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR