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

Model Number	RUBELLA IGG
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's sample was sent to the manufacturer for investigation.The investigation found a general reagent issue can be excluded.The results reported by the customer are comparable to the results obtained by the investigation.The investigation is ongoing.
Event or Problem Description
There was a complaint of questionable elecsys rubella igg results for 1 patient tested with a cobas e801 module serial number (b)(4).The questionable results were reported outside the laboratory to the physician.The patient¿s sample was also tested with a diasorin and another unknown method.The patient¿s e801 result on (b)(6) 2021 was 72.1 ui/i, reactive.The patient¿s e801 result on (b)(6) 2021 was 59.4 ui/i, reactive.The patient¿s diasorin result on (b)(6) 2021 was 5.0 ui/i, negative.The patient¿s unknown method result was negative.The elecsys rubella igg used on (b)(6) 2021 was lot 58675801 and had an expiration date of 31-oct-2022.
Additional Manufacturer Narrative
The patient sample was received and investigated with the following results: 1.Elecsys rubella igg: 65 iu/ml reactive 2.Elecsys rubella igm: 0.250 coi non-reactive (for information) 3.Platelia rubella igg: negative 4.Neutralization (r&d in-house verification): successful => presence of anti-rubella igg antibodies verified 5.Mirkogen blot rubella igg: negative the successful neutralization clearly supports a true positivity of this sample.The platelia rubella igg, though negative, is at an enhanced level and therefore also slightly supporting a positive result.Interestingly, the blot is totally negative and does not at all support a positive result.Such a constellation was not observed up to now and is extremely difficult to interpret.As there are more results pointing to a content of specific rubella igg in this sample (positive elecsys rubella igg, successful neutralization and enhanced level in the platelia rubella igg) the sample is more likely correct positive in the elecsys rubella igg.The investigation determined the elecsys rubella igg reagent performs within specification.

• Brand Name: ELECSYS RUBELLA IGG
• 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: 13383690
• Report Number: 1823260-2022-00223
• Device Sequence Number: 4945894
• Product Code: LFX
• UDI-Device Identifier: 04015630940240
• UDI-Public: 04015630940240
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/15/2022

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: 05/31/2022
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 07027770190
• Device Lot Number: 557520, 58675801
• 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: 01/03/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/15/2022
• 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: 36 YR
• Patient Sex: Female