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

Model Number RUBELLA IGG

Device Problem False Negative Result (1225)

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

Event Date 09/17/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received false negative results for one patient tested with the elecsys rubella igg immunoassay on a cobas e 801 module serial number (b)(4).The reporter stated they received reproducible negative results on several samples from the same patient that when tested on a diasorin, a centaur and an immulite resulted in reactive results.The patient¿s e801 result on (b)(6) 2021 was 4.36 iu/ml (negative).The patient¿s e801 result on (b)(6) 2021 was 4.08 iu/ml (negative).The patient¿s e801 result on (b)(6) 2021 was 2.60 iu/ml (negative).The patient¿s diasorin result on (b)(6) 2021 was 41.0 iu/ml (reactive).The patient¿s centaur result on (b)(6) 2021 was 22.0 iu/ml (reactive).The patient¿s immulite result on (b)(6) 2021 was 17 iu/ml (reactive).The patient¿s e801 result on (b)(6) 2021 was 1.74 iu/ml (negative).The questionable results were reported outside of the laboratory.

Manufacturer Narrative

The patient¿s sample was received for investigation and tested on a cobas e801.Results: rubella igm: 0.242 coi (nonreactive).Rubella igg: 4.33 iu/ml (nonreactive).The results reported by the customer are comparable to the results obtained by the investigation.The investigation is ongoing.Expiration date continued: 28-feb-2022.

Manufacturer Narrative

The negative result for this sample that was provided from the customer for the elecsys rubella igg was confirmed by roche internally.Further investigation with the platelia rubella igg showed ~ 3 iu/ml, which is negative but a slightly enhanced value.The mikrogen recomblot rubella igg was positive with the only a strong band for e2.Overall, this is a mixture of results not clearly pointing to a positive or a negative result for this sample.The platelia rubella igg, though negative, is at a slightly enhanced level above baseline and therefore somewhat supporting a positive result.Interestingly, the blot is positive and supports a positive result.Taking into consideration also the positive results for several competitor assays as provided by the customer this sample is probably positive for rubella igg.The elecsys rubella igg is likely false negative with this sample.Based on data presented in product labeling, false results can occur.Product labeling also states, "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the elecsys rubella igg reagent performs within specification.

• Brand Name: ELECSYS RUBELLA IGG
• 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: 13422224
• MDR Text Key: 291944499
• Report Number: 1823260-2022-00268
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072617
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: 557520, 533269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• 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
• Patient Age: 41 YR
• Patient Sex: Female