MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGG IMMUNOASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Catalog Number 04618793160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received a questionable low elecsys rubella igg immunoassay result for one patient sample from cobas 8000 e 602 module serial number (b)(4).The customer stated that they have another testing laboratory on site that only performs panels.The ordering physician sent an order for a panel test and also for rubella igg as a single test.The initial result was 2.18 iu/ml (negative), but the result for the panel sample tested on an athena instrument had a positive result.The sample was sent for testing by a "send out" test and was positive.The sample was repeated on (b)(6) 2017 with a result of 3.52 iu/ml (negative) and on (b)(6) 2017 with a result of 3.73 iu/ml (negative) from the cobas 8000 e 602 module.The results were reported outside of the laboratory.The positive result was believed to be correct.The patient was not adversely affected.The customer stated they performed a correlation between the athena instrument and the cobas 8000 e 602 module and found no other discrepancies.The field service representative inspected the system and could not find a cause.He ran performance testing which all passed.The customer ran calibrations and qc and was satisfied with the results.

Manufacturer Narrative

A specific root cause could not be identified as no sample material was available for further investigation.

• Brand Name: ELECSYS RUBELLA IGG IMMUNOASSAY
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• 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: 7033623
• MDR Text Key: 93191338
• Report Number: 1823260-2017-02622
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 11/30/2017
• Device Catalogue Number: 04618793160
• Device Lot Number: 20619404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/28/2017
• 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