MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGM; RUBELLA VIRUS IMMUNOGLOBULIN M (IGM)

Catalog Number	07027796190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc results were within range.Sample from the patient was received for further investigation and the customer's results were reproduced.The sample was tested on an e801 module: rubella igm result with reagent lot 523730 was 0.773 coi (non reactive).Rubella igg result with reagent lot 533269 was 16 iu/ml (reactive).A general reagent issue was excluded and no product problem was found.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys rubella igm immunoassay result from cobas e801 module serial number (b)(4).On (b)(6) 2021, the elecsys rubella igm result was 0.599 coi (non-reactive).On (b)(6) 2021, the elecsys rubella igm result was 0.598 coi (non-reactive).On (b)(6) 2021, the elecsys rubella igm result was 0.617 coi (non-reactive).On (b)(6)2021, the result from another laboratory by elisa method was positive.All results were from the same patient sample.It was not known if any questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation determined the results provide evidence that the correct result for the sample was likely positive for rubella igm.The results are consistent with a fresh infection of the patient.Per product labeling, specimens taken very early in the acute phase of infection may not contain detectable amounts of rubella igm antibodies.It was determined there was no malfunction of the reagent.

• Brand Name: ELECSYS RUBELLA IGM
• Common Device Name: RUBELLA VIRUS IMMUNOGLOBULIN M (IGM)
• 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: 12712203
• Report Number: 1823260-2021-03151
• Device Sequence Number: 17203303
• Product Code: LFX
• UDI-Device Identifier: 04015630940257
• UDI-Public: 04015630940257
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K092322
• 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): 12/01/2021

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: 10/31/2021
• Device Catalogue Number: 07027796190
• Device Lot Number: 523730
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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 Sex: Unknown