MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOXO IGG IMMUNOASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Catalog Number	04618815160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of questionable elecsys toxo igg immunoassay results from 2 separate samples (sample a and sample b) from the same patient tested on a cobas 6000 e 601 module compared to the results from a competitor's system.The competitor's system was believed to be an abbott.For sample a the initial toxo igg result from a cobas e601 was 119 iu/ml, positive.The initial result was released to the doctor but was questioned.The patient sample was tested in another laboratory using a competitor's system and the toxo igg result was negative.For sample b that was collected on (b)(6) 2018, the initial toxo igg result from a cobas e601 was 118.6 iu/ml, positive.The same sample was retested and the initial result was confirmed, no specific details provided.The cobas e601 serial number was (b)(4).It was noted that the customer was not following the calibration and qc testing frequency recommended in product labeling.The investigation is currently ongoing.
Additional Manufacturer Narrative
The most recent calibration and qc results were acceptable.A sample from the patient was submitted for further investigation and te customer's reactive toxo igg results were reproduced.The sample was confirmed positive for toxo igg using recomline blot assay method.It was determined the reagent was performing within specifications.

• Brand Name: ELECSYS TOXO IGG IMMUNOASSAY
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7813447
• Report Number: 1823260-2018-02852
• Device Sequence Number: 1514281
• Product Code: LGD
• UDI-Device Identifier: 04015630939336
• UDI-Public: 04015630939336
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K073501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 10/31/2018
• Device Catalogue Number: 04618815160
• Device Lot Number: 28840704
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1