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 Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of false positive elecsys cmv igg assay results for 1 patient sample on the cobas 8000 e 801 module.The e 801 module serial number was asked for not provided.The initial cmv igg result was >500 u/ml.Using a different sample tube from the same blood collection, the cmv igg results were 492 u/ml, 490 u/ml, 487 u/ml, and 428 u/ml.The cmv igg result was < 4 ua/ml with the vidas biomerieux method.It was not clear which sample tube was used.On (b)(6) 2018 a new sample was collected and the cmv igg result was 500 u/ml with a data flag.The sample was repeated with a 1:20 dilution and the cmv igg result was 437 u/ml.The cmv igg reagent lot number was 252325 with an expiration date of 30-sep-2018.There was no allegation of an adverse event.The sample was provided for investigation and the result was non-reactive.The customer's cmv igg result was not confirmed.The provided qc data was acceptable.A general reagent issue was excluded.The investigation was unable to find a definitive root cause.

• 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: 7748234
• MDR Text Key: 116092238
• Report Number: 1823260-2018-02600
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 04015630923489
• UDI-Public: 4015630923489
• Combination Product (y/n): N
• Reporter Country Code: LU
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 04784596190
• Device Lot Number: 252325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2018
• 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