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 Consequences Or Impact To Patient (2199)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for two patient samples tested for igm antibodies to cytomegalovirus (cmv igm) on an e601 analyzer.It was asked, but it is not known if the erroneous results were reported outside of the laboratory.The first sample initially resulted as 0.448 coi (non-reactive) on the e601 analyzer.The sample was repeated at a different laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as 1.90 ratio (positive).The sample was also repeated on the e601 analyzer on (b)(6) 2016, resulting as 0.462 coi (non-reactive).The second sample, from a (b)(6) female, initially resulted as 0.564 coi (non-reactive) on the e601 analyzer on (b)(6) 2016.The sample was repeated at a different laboratory on an abbott architect analyzer on (b)(6) 2016, resulting as 1.10 ratio (positive).The patients were not adversely affected.The e601 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Samples from the first patient were provided for investigation.A sample from the second patient was not available for investigation.Investigation of the first patient sample was able to confirm the customer's results.The sample showed (b)(6), but was still (b)(6) the cut-off for the elecsys cmv igm assay.The sample was (b)(6) when tested with the recomline cmv igm assay.The (b)(6) of the detected antibodies suggest that the first patient may have encountered a primary infection with (b)(6) 18-20 weeks prior to the sampling on (b)(6) 2016.The previous sample from this patient measured on (b)(6) 2015 did not show (b)(6) in the performed assays, indicating that the time point of infection must have been in close proximity to the first sampling date.Apparently, at this earlier time point significant antibody titers had not formed yet.Moreover, the later sample shows an only (b)(6) igm titer suggesting that this patient developed a (b)(6) response only, which renders early detection challenging.Alternatively, the maturation of igg antibodies might occur faster than average in this particular patient and the time point of primary infection was between the two samplings.No medical device problem was found.

• 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: 5669559
• MDR Text Key: 45596467
• Report Number: 1823260-2016-00665
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 187017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2016
• 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: 29 YR