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

Catalog Number 04618793190

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).(b)(6).

Event Description

The customer reported that they saw an implausible shift up in patient results when switching from igg antibodies to rubella virus (rubella igg) reagent lot number 182963 to lot number 185927.Monitoring the two affected patients over time revealed the up-shift of rubella igg values.The results for two patient samples were provided and results from reagent lot number 185927 were considered to be erroneous (falsely positive).The results for each patient were reported outside of the laboratory and each patient's physician questioned the up-shift in results.The first patient sample initially resulted as 9.15 iu/ml with reagent lot number 182963.The sample was repeated with reagent lot number 185927 and resulted as 15.99 iu/ml.The second patient sample initially resulted as 9.49 iu/ml with reagent lot number 182963.The sample was repeated with reagent lot number 185927 and resulted as 11.68 iu/ml.The sample was also repeated a second time with reagent lot number 185927 and resulted as 11.87 iu/ml.The patients were not adversely affected.The samples were tested on and e602 module analyzer serial number (b)(4).Control recovery for each lot number was found to be within expected ranges.

Manufacturer Narrative

Investigations of quality control release data have confirmed that recovery with kit lot 185927 is slightly higher when compared to kit lot 182963.However, the recovery is within specifications for both reagent lots.

Manufacturer Narrative

The investigation determined that samples with a concentration close to the cut-off may give different qualitative results, 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: 4996684
• MDR Text Key: 23424232
• Report Number: 1823260-2015-03958
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/06/2015

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: 08/12/2015
• 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