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

Catalog Number 04618793190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

The customer received questionable low igg antibodies to rubella virus results for one patient from cobas e601 serial number (b)(4).With reagent lot 182963, it appeared the patient was not immunized, but with reagent lot 185927 it appeared the patient was immunized.The results were reagent lot 182963 were: (b)(6) 2015: 6.0.06/09/2015: 6.3.The results were reagent lot 185927 were: (b)(6) 2015: 11.47 and 11.52.(b)(6) 2015: 12.08 and 12.48.(b)(6) 2015: 12.5 and 13.1.The results from (b)(6) 2015 and (b)(6) 2015 were reported to the patient and the prescriber.The patient was not adversely affected.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be identified.Further investigation confirmed the samples were truly positive.It was noted both reagent lots performed within the specifications for qc.Due to the heterogeneity of the analyte, lot-to-lot variations cannot be completely excluded.

Manufacturer Narrative

Samples from the patient were submitted for investigation.The customer's negative results with reagent lot 182963 and positive results with reagent lot 185927 were reproduced.

• Brand Name: IGG ANTIBODIES TO RUBELLA VIRUS
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4962618
• MDR Text Key: 6257073
• Report Number: 1823260-2015-03917
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/13/2015

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 Expiration Date: 11/30/2015
• Device Catalogue Number: 04618793190
• Device Lot Number: 182963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 07/21/2015
• Initial Date FDA Received: 08/03/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 039 YR