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

Catalog Number	04618793160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample from (b)(6) 2021 (sample 3) was sent for investigation and was tested on a cobas e602 with retention kits.The elecsys rubella igg immunoassay investigation result was 21.23 iu/ml, a positive result; the elecsys rubella igm immunoassay investigation result was 0.272 coi (non-reactive).The investigation is ongoing.
Event or Problem Description
There was a complaint of discrepant elecsys rubella igg immunoassay (igg) results for 1 patient tested with a cobas 8000 e602 module.The discrepant results were not reported outside the laboratory.The patient¿s sample 1 initial igg result in july 2021 was 6.66 ui/ml and the sample received an elecsys rubella igm immunoassay (igm) result of 0.2 coi.Both initial igg and igm results were negative.The patient's sample 2 was run twice on (b)(6) 2021.The first igg result was 13.08 ui/ml and the sample received an igm result of 0.2 coi.The repeat igg result was 12.59 ui/ml on (b)(6) 2021.Both igg results were positive while the igm result was negative.The patient¿s sample 3 was run on (b)(6) 2021 with an igg result of 21.67 ui/ml and an igm result of 0.2 coi; and repeated on a diasorin analyzer where it got negative results for both igg and igm.The cobas results were positive for igg and negative for igm.The patient had a rubella igg result of 20.93 ui/ml on (b)(6) 2021.It is unknown if the patient is vaccinated for rubella.
Additional Manufacturer Narrative
The calibration from 06-aug-2021 met acceptance criteria.The qc from 03-sep-2021 met acceptance criteria.No qc data was provided for 19-jul- and 06-aug-2021.The investigation found no issues with the reagent.The investigation found the customer¿s positive result for elecsys rubella igg was reproducible with a value of ~21 iu/ml.The investigation tested the patient's sample with the mikrogen recomblot, platelia rubella igg, and a neutralization experiment.All results supported the positive elecsys rubella igg result.The investigation did not identify a product problem.

• Brand Name: ELECSYS RUBELLA IGG IMMUNOASSAY
• Common Device Name: 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: 12546663
• Report Number: 1823260-2021-02849
• Device Sequence Number: 5159283
• Product Code: LFX
• UDI-Device Identifier: 04015630939251
• UDI-Public: 04015630939251
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 04618793160
• Device Lot Number: 53329902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female