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

Model Number RUBELLA IGG

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

Country of origin is (b)(6).A qc test and 2 calibrations were run the day of the event, all with acceptable results sample from the patient was received for investigation.The customer's reactive result was reproduced.No specific reagent issue could be identified.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys rubella igg immunoassay results from the cobas 6000 e 601 module analyzer serial number of (b)(4).The initial result was 13.06 iu/ml (positive).The rerun result on the diasorin liaison was < 3 iu/ml (negative) and the rerun result on the abbott alinity on (b)(6) 2019 was 1.6 iu/ml (negative).The questionable results were reported outside the laboratory.

Manufacturer Narrative

Further investigations of the patient sample confirmed the customer's results.The platelia rubella igg result was 6.09 ie/ml negative.Neutralization could not provide a conclusion as there was no significant signal reduction.The recom blot rubella igg result was positive (e1+).The correct rubella igg result for the patient sample was positive.

• 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
• MDR Report Key: 9251168
• MDR Text Key: 218508885
• Report Number: 1823260-2019-03878
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

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: 03/31/2020
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 403577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR