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

Catalog Number	07028008190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys toxo igg immunoassay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.The sample was initially tested on the e 801 analyzer, but there was no value, only a flag indicating there was a sample clot.The sample was repeated on the e 801 analyzer, resulting in a toxo igg value of 50.2 iu/ml (reactive).The sample was repeated on a biomnis analyzer, resulting in a value of < 6.1 (negative, no units provided).The serial number of the e 801 analyzer is (b)(4).
Additional Manufacturer Narrative
Calibration data was within expected ranges.Quality control recovery was within specifications.The investigation determined the issue is consistent with incorrect pre-analytic handling of the sample.

• 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
• 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: 13120292
• Report Number: 1823260-2021-03946
• Device Sequence Number: 11917311
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K073501
• 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): 02/14/2022

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: 02/28/2022
• Device Catalogue Number: 07028008190
• Device Lot Number: 53467701
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/14/2022
• 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: 29 YR
• Patient Sex: Female