MAUDE Adverse Event Report: ROCHE DIAGNOSTICS RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Catalog Number 07027770190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable high elecsys rubella igg immunoassay results for three samples from one patient.The patient was a pregnant woman who had been tested for rubella in another laboratory using an abbott architect analyzer.The two first samples from the patient were negative.No specific data was provided.On (b)(6) 2017, the third sample from the patient was tested on cobas 8000 e 801 analyzer serial number (b)(4) and the result was 30 ui/l(reactive).The customer then retested the first two samples from the patient on the cobas 8000 e 801 analyzer and the results were reactive.No specific data was provided.All three samples were tested in another laboratory on a vidas (biomerieux) analyzer and the results were all negative.No specific data was provided.Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown.There was no allegation of an adverse event.

Manufacturer Narrative

The sample from (b)(6) 2017 was submitted for investigation.The following results were obtained: platelia rubella igg: negative, mikrogen recomblot rubella igg: indeterminate, and neutralization testing found a clear signal reduction, which indicated the presence of specific antibodies.Based on these results, a precise conclusion was not possible.The final result for the sample was regarded as indeterminate.As all assays indicated a low level of specific antibodies, it was likely that specific antibodies against rubella were present in the sample.All calibration and qc data provided was within the expected ranges.The assay elecsys rubella igg was found to be performing within specification.

• Brand Name: RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS
• 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: 6823458
• MDR Text Key: 83862026
• Report Number: 1823260-2017-01827
• Device Sequence Number: 1
• Product Code: LFX
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 07027770190
• Device Lot Number: 18164500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 11/06/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR