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

Catalog Number 04618793190

Device Problem High Test Results (2457)

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

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

This event ocurred in (b)(6).

Event Description

The customer noticed a shift high in qc results for igg antibodies to rubella virus when changing to a new reagent lot.The customer tested patient samples with both lot numbers of reagent on cobas e601 serial number (b)(4).Of the data provided for 18 patient samples, the results for two patient samples were discrepant.Patient 1 result with reagent lot 182963 was 8 (non-reactive).The result with reagent lot 185927 was 10 (reactive).Patient 2 result with reagent lot 182963 was 9 (non-reactive).The result with reagent lot 185927 was 12 (reactive).Information concerning if any discrepant result was reported outside the laboratory or if any patient was adversely affected was requested, but was not provided.

Manufacturer Narrative

The investigation found both reagent lots performed within the specified ranges of the assay.However, some samples may show differences in quantitative results.This is prominent for samples close to the cut off.Samples with a concentration close to the cut-off may give different qualitative results, meaning non-reactive versus reactive.

• 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: 5050042
• MDR Text Key: 25122058
• Report Number: 1823260-2015-04078
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 10/01/2015

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 Catalogue Number: 04618793190
• Device Lot Number: 185927
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1