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

Catalog Number 07027796190

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 278826030
• Report Number: 1823260-2021-03151
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630940257
• UDI-Public: 04015630940257
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K092322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/11/2021
• 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
• Patient Sequence Number: 1