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

Catalog Number 04784596190

Device Problem High Test Results (2457)

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

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of false positive results for 1 patient tested for elecsys (b)(6) and elecsys toxo igg immunoassay (toxo igg).This medwatch will cover (b)(6).Refer to medwatch with patient identifier (b)(6) for information on the toxo igg erroneous results.On (b)(6) 2017 the patient had a toxo igg result that was negative (the actual result was not provided) and a (b)(6) result that was (b)(6) (the actual result was not provided).On (b)(6) 2017 a new sample was obtained and the (b)(6) result was 134.5 u/ml ((b)(6)).The sample was repeated and the result was 134.4 u/ml (positive).The toxo igg result was 164.0 iu/ml (positive).The sample was repeated and the result was 165.5 iu/ml ((b)(6)).These results were reported outside of the laboratory.On (b)(6) 2017 the initial sample from (b)(6) 2017 was repeated and the (b)(6) result was 0.150 u/ml with a data flag ((b)(6)) and the toxoplasma igg result was 0.130 iu/ml with a data flag (negative).A new sample was obtained on (b)(6) 2017 and the patient¿s (b)(6) result was 0.150 u/ml ((b)(6)) and the patient¿s toxoplasma igg result was 0.130 iu/ml (negative).No adverse event was reported.The instrument type and serial number were not provided.The customer has excluded a sample mix up or a preanalytic issue because she measured each of the 3 samples from the patient and confirmed the results herself.

Manufacturer Narrative

The patient samples from (b)(6) 2017 and (b)(6) 2017 were submitted for investigation.The samples were tested using various methods: elecsys cmv igg, elecsys cmv igg avidity, recomline cmv igg, elecsys toxo igg, an in-house neutralization assay, elecsys toxo igg avidity and recomline toxo igg.The results using the various methods were reproducible.The (b)(6) 2017 sample showed clear reactivity using the elecsys cmv igg assay.The detected antibodies were of high avidity and reactivity.This suggests that cmv directed antibodies were present in the sample.This is additionally supported by the recomline cmv assay results.The sample from (b)(6) 2017 was confirmed to be non-reactive for all cmv assays.Based on investigations performed, the cmv igg and toxo igg results for both samples are considered to be correct.The reactivity pattern of the samples over the course of 6 days does not correspond to a humoral immune response.A specific root cause was not identified.Possible root causes may be related to sample contamination or a sample mix-up.Both reagents perform within specification.

• Brand Name: CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUS
• 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: 6646180
• MDR Text Key: 77868757
• Report Number: 1823260-2017-01247
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131605
• 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
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04784596190
• Device Lot Number: 174473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• 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: 23 YR